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Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF) (CONSORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00249834
Recruitment Status : Completed
First Posted : November 7, 2005
Results First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infertility
Interventions Drug: Gonal-f
Drug: Recombinant human chorionic gonadotrophin (r-hCG)
Enrollment 166
Recruitment Details  
Pre-assignment Details A total of 166 subjects received at least 1 dose of recombinant human follicle stimulating hormone (r-hFSH). Of these, 161 subjects received r-hFSH in a dose group of 5 or more subjects. As per statistical analysis plan, only dose groups having 5 or more subjects were to be analyzed for efficacy and safety analysis in this study.
Arm/Group Title Gonal-f 37.5 IU Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU Gonal-f 262.5 IU Gonal-f 300 IU
Hide Arm/Group Description GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 37.5 International Units (IU) per day based on assisted reproductive technology (ART) treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter were developed, a single injection of 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 262.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 300 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Period Title: Overall Study
Started 1 48 45 34 24 10 2 2
Completed 0 29 31 26 19 8 1 2
Not Completed 1 19 14 8 5 2 1 0
Reason Not Completed
Ovarian stimulation failed             1             0             0             0             0             0             0             0
Failure of down-regulation             0             0             0             0             0             0             1             0
Protocol Violation             0             19             14             8             5             2             0             0
Arm/Group Title Gonal-f 37.5 IU Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU Gonal-f 262.5 IU Gonal-f 300 IU Total
Hide Arm/Group Description GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 37.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 262.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 300 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. Total of all reporting groups
Overall Number of Baseline Participants 1 48 45 34 24 10 2 2 166
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 48 participants 45 participants 34 participants 24 participants 10 participants 2 participants 2 participants 166 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
48
 100.0%
45
 100.0%
34
 100.0%
24
 100.0%
10
 100.0%
2
 100.0%
2
 100.0%
166
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 48 participants 45 participants 34 participants 24 participants 10 participants 2 participants 2 participants 166 participants
Female
1
 100.0%
48
 100.0%
45
 100.0%
34
 100.0%
24
 100.0%
10
 100.0%
2
 100.0%
2
 100.0%
166
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Oocytes Retrieved
Hide Description Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame Ovum pick up day (34 to 38 hours post r-hCG administration)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. Here "overall number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.
Arm/Group Title Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Hide Arm/Group Description:
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Overall Number of Participants Analyzed 34 39 31 22 9
Mean (Standard Deviation)
Unit of Measure: Oocytes
8.3  (4.5) 9.6  (6.5) 12.1  (6.4) 12.7  (4.3) 8.3  (3.8)
2.Secondary Outcome
Title Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)
Hide Description As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame up to end of stimulation cycle (approximately 31 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.
Arm/Group Title Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Hide Arm/Group Description:
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Overall Number of Participants Analyzed 48 45 34 24 10
Mean (Standard Deviation)
Unit of Measure: International Units (IU)
1102.3  (671.8) 1287.2  (447.0) 1632.4  (341.5) 2043.8  (276.2) 2572.5  (552.3)
3.Secondary Outcome
Title Mean Number of Ovarian Stimulation Days
Hide Description The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame up to end of stimulation cycle (approximately 31 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.
Arm/Group Title Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Hide Arm/Group Description:
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Overall Number of Participants Analyzed 48 45 34 24 10
Mean (Standard Deviation)
Unit of Measure: Days
12.5  (4.4) 11.0  (2.9) 10.6  (1.8) 11.0  (1.4) 11.5  (2.4)
4.Secondary Outcome
Title Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH
Hide Description As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame up to end of stimulation cycle (approximately 31 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.
Arm/Group Title Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Hide Arm/Group Description:
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Overall Number of Participants Analyzed 48 45 34 24 10
Measure Type: Number
Unit of Measure: Percentage of cycles
Excessive response 0.0 0.0 2.9 0.0 0.0
Inadequate response 25.0 8.9 8.8 8.3 20.0
5.Secondary Outcome
Title Number of Subjects Needing Dose Adjustment
Hide Description Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame 6 days post r-hFSH treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.
Arm/Group Title Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Hide Arm/Group Description:
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Overall Number of Participants Analyzed 48 45 34 24 10
Measure Type: Number
Unit of Measure: subjects
Increase 7 3 3 1 0
Decrease 0 0 1 2 1
Increase and decrease both 2 3 0 0 0
6.Secondary Outcome
Title Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose
Hide Description As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame up to end of stimulation cycle (approximately 31 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.
Arm/Group Title Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Hide Arm/Group Description:
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Overall Number of Participants Analyzed 48 45 34 24 10
Mean (Standard Deviation)
Unit of Measure: IU/day
84.4  (21.6) 114.7  (16.4) 153.6  (12.8) 186.5  (5.8) 223.3  (5.3)
7.Secondary Outcome
Title Embryo Implantation Rate
Hide Description Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame 35-42 days post r-hCG administration
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. Here "overall number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.
Arm/Group Title Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Hide Arm/Group Description:
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Overall Number of Participants Analyzed 32 37 29 22 7
Mean (Standard Deviation)
Unit of Measure: Percent sacs per embryo
36.5  (42.8) 24.3  (35.0) 28.2  (38.9) 37.1  (40.5) 11.9  (20.9)
8.Secondary Outcome
Title Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate
Hide Description Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame 35-42 days post r-hCG administration
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.
Arm/Group Title Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Hide Arm/Group Description:
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Overall Number of Participants Analyzed 48 45 34 24 10
Measure Type: Number
Unit of Measure: Percentage of subjects
Total pregnancy 17 18 16 16 2
Clinical pregnancy 15 14 12 12 2
Multiple pregnancy 3 2 4 3 0
Time Frame [Not Specified]
Adverse Event Reporting Description As per statistical analysis plan, safety analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
 
Arm/Group Title Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Hide Arm/Group Description GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
All-Cause Mortality
Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/48 (6.25%)   3/45 (6.67%)   1/34 (2.94%)   1/24 (4.17%)   0/10 (0.00%) 
Infections and infestations           
Urinary tract infection * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
Abortion * 1  1/48 (2.08%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Ectopic pregnancy * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Imminent abortion * 1  1/48 (2.08%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Reproductive system and breast disorders           
Ovarian hyperstimulation syndrome * 1  2/48 (4.17%)  0/45 (0.00%)  0/34 (0.00%)  1/24 (4.17%)  0/10 (0.00%) 
Ovarian torsion * 1  0/48 (0.00%)  0/45 (0.00%)  1/34 (2.94%)  0/24 (0.00%)  0/10 (0.00%) 
Pelvic pain * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Vascular disorders           
Jugular vein thrombosis * 1  1/48 (2.08%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gonal-f 75 IU Gonal-f 112.5 IU Gonal-f 150 IU Gonal-f 187.5 IU Gonal-f 225 IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/48 (22.92%)   15/45 (33.33%)   5/34 (14.71%)   10/24 (41.67%)   3/10 (30.00%) 
Gastrointestinal disorders           
Abdominal pain upper * 1  0/48 (0.00%)  0/45 (0.00%)  2/34 (5.88%)  0/24 (0.00%)  0/10 (0.00%) 
Diarrhoea * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Nausea * 1  1/48 (2.08%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Abdominal pain * 1  0/48 (0.00%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  1/10 (10.00%) 
General disorders           
Injection site pain * 1  0/48 (0.00%)  2/45 (4.44%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Fatigue * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Oedema peripheral * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Infections and infestations           
Influenza * 1  1/48 (2.08%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  1/10 (10.00%) 
Gastroenteritis * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Tonsillitis * 1  1/48 (2.08%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Vulvitis * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Pneumonia * 1  0/48 (0.00%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  1/10 (10.00%) 
Injury, poisoning and procedural complications           
Post procedural pain * 1  1/48 (2.08%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Nervous system disorders           
Headache * 1  2/48 (4.17%)  7/45 (15.56%)  0/34 (0.00%)  5/24 (20.83%)  1/10 (10.00%) 
Dizziness * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Myasthenic syndrome * 1  0/48 (0.00%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  1/10 (10.00%) 
Psychiatric disorders           
Anxiety * 1  0/48 (0.00%)  0/45 (0.00%)  0/34 (0.00%)  1/24 (4.17%)  0/10 (0.00%) 
Reproductive system and breast disorders           
Vaginal haemorrhage * 1  3/48 (6.25%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Adnexa uteri pain * 1  1/48 (2.08%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Metrorrhagia * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Ovarian cyst * 1  0/48 (0.00%)  0/45 (0.00%)  1/34 (2.94%)  0/24 (0.00%)  0/10 (0.00%) 
Vulvovaginal discomfort * 1  1/48 (2.08%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Breast pain * 1  0/48 (0.00%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  1/10 (10.00%) 
Ovarian hyperstimulation syndrome * 1  1/48 (2.08%)  2/45 (4.44%)  1/34 (2.94%)  3/24 (12.50%)  1/10 (10.00%) 
Pelvic pain * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  1/24 (4.17%)  1/10 (10.00%) 
Ovarian torsion * 1  0/48 (0.00%)  0/45 (0.00%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
Surgical and medical procedures           
Uterine operation * 1  0/48 (0.00%)  0/45 (0.00%)  1/34 (2.94%)  0/24 (0.00%)  0/10 (0.00%) 
Vascular disorders           
Flushing * 1  0/48 (0.00%)  1/45 (2.22%)  0/34 (0.00%)  0/24 (0.00%)  0/10 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00249834    
Other Study ID Numbers: 25198
First Submitted: November 4, 2005
First Posted: November 7, 2005
Results First Submitted: August 29, 2017
Results First Posted: March 30, 2018
Last Update Posted: March 30, 2018