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Trial record 81 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

EXpression PRofile Endometrium Samples Study (EXPRESS)

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: NCT01210144
Recruitment Status : Terminated (Study terminated due to recruitment failure)
First Posted : September 28, 2010
Results First Posted : November 14, 2012
Last Update Posted : December 27, 2013
Sponsor:
Collaborator:
Merck Serono S.A.S, France
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition In Vitro Fertilization
Interventions Drug: Gonal -f® [r-hFSH]
Drug: Ovitrelle® [r-hCG alfa]
Drug: Gonadotropin-releasing hormone (GnRH) Agonist
Drug: Gonadotropin-releasing hormone (GnRH) Antagonist
Enrollment 27
Recruitment Details  
Pre-assignment Details A total of 27 participants were enrolled in the study, out of which 2 participants withdrew the consent and 1 participant was excluded since endometrial biopsy was not possible.
Arm/Group Title Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Hide Arm/Group Description Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) gonadotropin-releasing hormone (GnRH) agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol. Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
Period Title: Overall Study
Started 13 11
Completed 10 11
Not Completed 3 0
Reason Not Completed
Lack of ovarian response             1             0
No fertilization             1             0
No transfer             1             0
Arm/Group Title Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) Total
Hide Arm/Group Description Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol. Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol. Total of all reporting groups
Overall Number of Baseline Participants 13 11 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 11 participants 24 participants
29.8  (4.2) 31.0  (4.4) 30.4  (4.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 11 participants 24 participants
Female
13
 100.0%
11
 100.0%
24
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Gene Expression of the Endometrium Following 1 Cycle With Gonal-f®
Hide Description A list of genes based on gene expression profiling carried out on ribonucleic acid (RNA) extracted from endometrial tissue. The expression of messenger ribonucleic acid (mRNA) in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.
Time Frame Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed for both agonist and antagonist protocol as total, which was the primary objective, since gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.
Arm/Group Title Gonal-f® + Ovitrelle®
Hide Arm/Group Description:
Participants received 150 IU per day of r-hFSH (Gonal-F®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm [for both long agonist and multi-dose antagonist protocol], and with E2>1 mcg/L [for long agonist protocol]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation, either 0.1 mg GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) in long agonist protocol or 0.25 mg GnRH antagonist daily was started from Day 6 of GONAL-f® stimulation treatment in multi-dose antagonist protocol, as per SmPC.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f®
Hide Description Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle) and Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).
Time Frame Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population: participants who received at least 1 dose of study drug. "N" (number of participants analyzed) signifies participants evaluable for this measure. Results for both agonist and antagonist protocol are presented as total since assessment of histological pattern for whole study population was the primary objective.
Arm/Group Title Gonal-f® + Ovitrelle®
Hide Arm/Group Description:
Participants received 150 IU per day of r-hFSH (Gonal-F®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm [for both long agonist and multi-dose antagonist protocol], and with E2>1 mcg/L [for long agonist protocol]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation, either 0.1 mg GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) in long agonist protocol or 0.25 mg GnRH antagonist daily was started from Day 6 of GONAL-f® stimulation treatment in multi-dose antagonist protocol, as per SmPC.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
Proliferative phase 2
Early secretory phase 15
Intermediate secretory phase 6
3.Secondary Outcome
Title Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer
Hide Description A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.
Time Frame Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.
Arm/Group Title Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Hide Arm/Group Description:
Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol
Hide Description A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.
Time Frame Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.
Arm/Group Title Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Hide Arm/Group Description:
Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol
Hide Description Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).
Time Frame Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included those participants who received at least one dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Hide Arm/Group Description:
Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
Overall Number of Participants Analyzed 12 11
Measure Type: Number
Unit of Measure: participants
Proliferative phase 1 1
Early secretory phase 8 7
Intermediate secretory phase 3 3
6.Secondary Outcome
Title Gene Expression in Participants Without Blastocyst Transfer
Hide Description A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.
Time Frame Day 5 or 6 (window of implantation) after Oocyte Retrieval
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.
Arm/Group Title Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Hide Arm/Group Description:
Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer
Hide Description Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).
Time Frame Day 5 or 6 (window of implantation) after Oocyte Retrieval
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: participants who received at least one dose of study medication. "N" (number of participants analyzed) signifies participants who were evaluable for this measure. Data were not analyzed for Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) group because there were no participants without blastocyst transfer in this group.
Arm/Group Title Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Hide Arm/Group Description:
Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
Overall Number of Participants Analyzed 2 0
Measure Type: Number
Unit of Measure: participants
Proliferative phase 0
Early secretory phase 0
Intermediate secretory phase 2
8.Secondary Outcome
Title Gene Expression in Participants With Good or Poor Response to Gonal-f®
Hide Description A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent. Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.
Time Frame Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.
Arm/Group Title Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Hide Arm/Group Description:
Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Participants With a Specific Histological Pattern of the Endometrium in Participants With Good or Poor Response to Gonal-f®
Hide Description Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase). Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.
Time Frame Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®
Hide Outcome Measure Data
Hide Analysis Population Description
Data for histological pattern of the endometrium in participants with good or poor response to Gonal-f were not summarized because the number of participants in each group with respect to ovarian response were too low.
Arm/Group Title Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Hide Arm/Group Description:
Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 15 days after the last Investigational Medicinal Product (IMP) administration or early termination
Adverse Event Reporting Description An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerge or worsen relative to baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
 
Arm/Group Title Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Hide Arm/Group Description Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol. Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
All-Cause Mortality
Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gonal-f® + Ovitrelle® (Long Agonist Protocol) Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/13 (15.38%)   1/11 (9.09%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/13 (7.69%)  0/11 (0.00%) 
Reproductive system and breast disorders     
Ovarian hyperstimulation syndrome * 1  1/13 (7.69%)  0/11 (0.00%) 
Pelvic pain * 1  0/13 (0.00%)  1/11 (9.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Gene expression of the endometrium could not be analyzed due to poor quality of biopsy samples (poor mRNA quality) and poor recruitment in the study.
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 Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01210144     History of Changes
Other Study ID Numbers: IMP 28364
2007-003938-41 ( EudraCT Number )
First Submitted: August 11, 2010
First Posted: September 28, 2010
Results First Submitted: August 30, 2012
Results First Posted: November 14, 2012
Last Update Posted: December 27, 2013