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Trial record 5 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation (FASHION)

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ClinicalTrials.gov Identifier: NCT02449889
Recruitment Status : Completed
First Posted : May 20, 2015
Results First Posted : June 10, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Infertility
Interventions Drug: highly purified human chorionic gonadotropin
Drug: recombinant human chorionic gonadotropin
Enrollment 176
Recruitment Details A total of 4 sites in Brazil randomized subjects to the trial.
Pre-assignment Details In total 245 subjects were screened. Of these, 69 were screening failures and 176 were randomized. All randomized subjects were exposed to investigational medicinal product (IMP).
Arm/Group Title HP-hCG IM HP-hCG SC rhCG SC
Hide Arm/Group Description

Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)

Highly purified human chorionic gonadotropin

Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)

Highly purified human chorionic gonadotropin

Recombinant human chorionic gonadotropin 250 µg SC

Recombinant human chorionic gonadotropin

Period Title: Overall Study
Started 58 58 60
Completed 57 52 59
Not Completed 1 6 1
Reason Not Completed
Adverse Event             1             2             0
Protocol Violation             0             4             1
Arm/Group Title HP-hCG IM HP-hCG SC rhCG SC Total
Hide Arm/Group Description

Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)

Highly purified human chorionic gonadotropin

Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)

Highly purified human chorionic gonadotropin

Recombinant human chorionic gonadotropin 250 µg SC

Recombinant human chorionic gonadotropin

Total of all reporting groups
Overall Number of Baseline Participants 58 58 60 176
Hide Baseline Analysis Population Description
The intention to treat (ITT) analysis set was defined as all randomized subjects. Subjects were analyzed according to planned (randomized) treatment. All relevant baseline data were summarized based on the ITT analysis set. The ITT analysis set included all 176 randomized subjects.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 60 participants 176 participants
<35 years
35
  60.3%
33
  56.9%
32
  53.3%
100
  56.8%
35-37 years
20
  34.5%
23
  39.7%
22
  36.7%
65
  36.9%
>=38 years
3
   5.2%
2
   3.4%
6
  10.0%
11
   6.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 60 participants 176 participants
Female
58
 100.0%
58
 100.0%
60
 100.0%
176
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 60 participants 176 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.7%
2
   3.4%
0
   0.0%
3
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  13.8%
5
   8.6%
10
  16.7%
23
  13.1%
White
49
  84.5%
51
  87.9%
50
  83.3%
150
  85.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Brazil Number Analyzed 58 participants 58 participants 60 participants 176 participants
58
 100.0%
58
 100.0%
60
 100.0%
176
 100.0%
1.Primary Outcome
Title Number of Oocytes Retrieved
Hide Description Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.
Time Frame Approximately 36 hours after hCG administration
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was defined as all randomized subjects. Subjects were analyzed according to planned (randomized) treatment.
Arm/Group Title HP-hCG IM HP-hCG SC rhCG SC
Hide Arm/Group Description:

Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)

Highly purified human chorionic gonadotropin

Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)

Highly purified human chorionic gonadotropin

Recombinant human chorionic gonadotropin 250 µg SC

Recombinant human chorionic gonadotropin

Overall Number of Participants Analyzed 58 58 60
Mean (Standard Deviation)
Unit of Measure: Number of oocytes
7.1  (4.6) 7.3  (4.8) 6.6  (4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HP-hCG IM, rhCG SC
Comments Mean number of oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC
Type of Statistical Test Non-Inferiority
Comments Treatment comparisons were done in a sequential manner. First non-inferiority (NI) was tested for HP-hCG IM compared to rhCG SC (lower limit of the 95% confidence interval (CI) > -3.0). If NI was demonstrated, NI was also to be tested for HP-hCG SC compared to rhCG SC.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-0.6 to 1.8
Estimation Comments ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HP-hCG SC, rhCG SC
Comments Mean number of oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC
Type of Statistical Test Non-Inferiority
Comments As step 2 in the pre-specified sequential testing, NI was tested for HP-hCG SC compared to rhCG SC.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-0.5 to 2.0
Estimation Comments ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.
2.Secondary Outcome
Title Number of Metaphase II (MII) Oocytes
Hide Description Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination.
Time Frame Prior to insemination (within 6 hours after oocyte retrieval)
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT analysis set was defined as all randomized subjects. Subjects were analyzed according to planned (randomized) treatment.

Note that only subjects with ICSI were included in this analysis, i.e. 58 subjects in the HP-hCG IM group, 55 subjects in the HP-hCG SC group and 57 subjects in the rhCG SC group.

Arm/Group Title HP-hCG IM HP-hCG SC rhCG SC
Hide Arm/Group Description:

Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)

Highly purified human chorionic gonadotropin

Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)

Highly purified human chorionic gonadotropin

Recombinant human chorionic gonadotropin 250 µg SC

Recombinant human chorionic gonadotropin

Overall Number of Participants Analyzed 58 55 57
Mean (Standard Deviation)
Unit of Measure: Number of MII oocytes
5.9  (3.7) 6.2  (3.5) 5.6  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HP-hCG IM, rhCG SC
Comments Number of MII oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC
Type of Statistical Test Non-Inferiority
Comments Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.6 to 1.5
Estimation Comments ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HP-hCG SC, rhCG SC
Comments Number of Mll oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC
Type of Statistical Test Non-Inferiority
Comments Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-0.4 to 1.6
Estimation Comments ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.
3.Secondary Outcome
Title Number of Fertilized (2 Pronuclei (2PN)) Oocytes
Hide Description Fertilization was assessed by counting the number of pronuclei, which was recorded as 0, 1, 2 or >2. Correct fertilization was defined as oocytes with 2PN.
Time Frame One day after oocyte retrieval
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was defined as all randomized subjects. Subjects were analyzed according to planned (randomized) treatment.
Arm/Group Title HP-hCG IM HP-hCG SC rhCG SC
Hide Arm/Group Description:

Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)

Highly purified human chorionic gonadotropin

Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)

Highly purified human chorionic gonadotropin

Recombinant human chorionic gonadotropin 250 µg SC

Recombinant human chorionic gonadotropin

Overall Number of Participants Analyzed 58 58 60
Mean (Standard Deviation)
Unit of Measure: Number of fertilized oocytes
4.4  (3.3) 4.7  (3.4) 4.2  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HP-hCG IM, rhCG SC
Comments Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG IM versus rhCG SC
Type of Statistical Test Non-Inferiority
Comments Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.6 to 1.3
Estimation Comments ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HP-hCG SC, rhCG SC
Comments Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG SC versus rhCG SC.
Type of Statistical Test Non-Inferiority
Comments Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.5 to 1.4
Estimation Comments ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.
4.Secondary Outcome
Title Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate
Hide Description Defined as percentage of subjects with positive beta hCG. A positive β hCG was confirmed by a blood test obtained 13-15 days after transfer.
Time Frame 13-15 days after transfer
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was defined as all randomized subjects. Subjects were analyzed according to planned (randomized) treatment.
Arm/Group Title HP-hCG IM HP-hCG SC rhCG SC
Hide Arm/Group Description:

Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)

Highly purified human chorionic gonadotropin

Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)

Highly purified human chorionic gonadotropin

Recombinant human chorionic gonadotropin 250 µg SC

Recombinant human chorionic gonadotropin

Overall Number of Participants Analyzed 58 58 60
Measure Type: Number
Unit of Measure: percentage of participants
50.0 37.9 36.7
5.Secondary Outcome
Title Clinical Pregnancy Rate
Hide Description Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.
Time Frame 5-6 weeks after transfer
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set was defined as all randomized subjects. Subjects were analyzed according to planned (randomized) treatment.
Arm/Group Title HP-hCG IM HP-hCG SC rhCG SC
Hide Arm/Group Description:

Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)

Highly purified human chorionic gonadotropin

Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)

Highly purified human chorionic gonadotropin

Recombinant human chorionic gonadotropin 250 µg SC

Recombinant human chorionic gonadotropin

Overall Number of Participants Analyzed 58 58 60
Measure Type: Number
Unit of Measure: percentage of participants
46.6 27.6 31.7
6.Secondary Outcome
Title Frequency of Adverse Events (AEs)
Hide Description The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented.
Time Frame AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented
Hide Outcome Measure Data
Hide Analysis Population Description
Safety was summarized based on the safety analysis set.The safety analysis set included all 176 subjects. Subjects were analyzed according to their actual treatment.
Arm/Group Title HP-hCG IM HP-hCG SC rhCG SC
Hide Arm/Group Description:

Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)

Highly purified human chorionic gonadotropin

Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)

Highly purified human chorionic gonadotropin

Recombinant human chorionic gonadotropin 250 µg SC

Recombinant human chorionic gonadotropin

Overall Number of Participants Analyzed 58 58 60
Measure Type: Number
Unit of Measure: Number of AEs
22 25 25
7.Secondary Outcome
Title Intensity of AEs
Hide Description The intensity of an TEAE would be classified using the following 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity [disturbing]) or severe (inability to work or perform usual activities [unacceptable]).
Time Frame AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety was summarized based on the safety analysis set.The safety analysis set included all 176 subjects. Subjects were analyzed according to their actual treatment.
Arm/Group Title HP-hCG IM HP-hCG SC rhCG SC
Hide Arm/Group Description:

Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)

Highly purified human chorionic gonadotropin

Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)

Highly purified human chorionic gonadotropin

Recombinant human chorionic gonadotropin 250 µg SC

Recombinant human chorionic gonadotropin

Overall Number of Participants Analyzed 58 58 60
Measure Type: Count of Participants
Unit of Measure: Participants
Any mild AE
14
  24.1%
18
  31.0%
22
  36.7%
Any moderate AE
8
  13.8%
6
  10.3%
3
   5.0%
Any severe AE
0
   0.0%
1
   1.7%
0
   0.0%
Time Frame AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months.
Adverse Event Reporting Description AEs with onset after IMP administration were considered treatment-emergent and are presented for the safety analysis set.
 
Arm/Group Title HP-hCG IM HP-hCG SC rhCG
Hide Arm/Group Description

Highly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM)

Highly purified human chorionic gonadotropin

Highly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC)

Highly purified human chorionic gonadotropin

Recombinant human chorionic gonadotropin 250 µg SC

Recombinant human chorionic gonadotropin

All-Cause Mortality
HP-hCG IM HP-hCG SC rhCG
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)      0/58 (0.00%)      0/60 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
HP-hCG IM HP-hCG SC rhCG
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/58 (1.72%)      1/58 (1.72%)      2/60 (3.33%)    
Pregnancy, puerperium and perinatal conditions       
Ectopic pregnancy  1  0/58 (0.00%)  0 1/58 (1.72%)  1 0/60 (0.00%)  0
Reproductive system and breast disorders       
Adnexal torsion  1  0/58 (0.00%)  0 0/58 (0.00%)  0 1/60 (1.67%)  1
Ovarian hyperstimulation syndrome  1  1/58 (1.72%)  1 0/58 (0.00%)  0 1/60 (1.67%)  1
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HP-hCG IM HP-hCG SC rhCG
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/58 (20.69%)      12/58 (20.69%)      11/60 (18.33%)    
Gastrointestinal disorders       
Nausea  1  3/58 (5.17%)  3 1/58 (1.72%)  1 1/60 (1.67%)  1
Nervous system disorders       
Headache  1  1/58 (1.72%)  1 4/58 (6.90%)  4 0/60 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Biochemical pregnancy  1  2/58 (3.45%)  2 6/58 (10.34%)  6 3/60 (5.00%)  3
Abortion spontaneous  1  0/58 (0.00%)  0 1/58 (1.72%)  1 3/60 (5.00%)  3
Haemorrhage in pregnancy  1  2/58 (3.45%)  2 3/58 (5.17%)  3 1/60 (1.67%)  2
Vanishing twin syndrome  1  3/58 (5.17%)  3 0/58 (0.00%)  0 0/60 (0.00%)  0
Reproductive system and breast disorders       
Pelvic pain  1  3/58 (5.17%)  3 0/58 (0.00%)  0 3/60 (5.00%)  3
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
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.
The only disclosure restriction on the Principal Investigator (PI) is that Sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the Sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Sponsor to seek patent protection of the invention.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Compliance
Organization: Ferring Pharmaceuticals
EMail: DK0-Disclosure@ferring.com
Layout table for additonal information
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02449889     History of Changes
Other Study ID Numbers: 000191
First Submitted: May 18, 2015
First Posted: May 20, 2015
Results First Submitted: October 12, 2018
Results First Posted: June 10, 2019
Last Update Posted: June 26, 2019