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

Study Overview
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Brief Summary
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This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation

Official Title
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A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Efficacy and Safety of Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation

Conditions
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Infertility

Intervention / Treatment
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* Drug: highly purified human chorionic gonadotropin
* Drug: recombinant human chorionic gonadotropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-menopausal females between the ages of 18 and 39 years Documented history of infertility Body mass index (BMI) between 17.5 and 32.0 kg/m2 Regular menstrual cycles Exclusion Criteria: Known endometriosis stage III and IV Known polycystic ovarian syndrome (PCOS) History of recurrent miscarriage History of more than three previous controlled ovarian stimulation cycles

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HP-hCG IM<br>highly purified human chorionic gonadotropin, intramuscularly (IM) | Drug: highly purified human chorionic gonadotropin<br> <br> * Other names: BREVACTID;|
| Experimental: HP-hCG SC<br>highly purified human chorionic gonadotropin, subcutaneously (SC) | Drug: highly purified human chorionic gonadotropin<br> <br> * Other names: BREVACTID;|
| Active Comparator: rhCG<br>recombinant human chorionic gonadotropin | Drug: recombinant human chorionic gonadotropin<br> <br> * Other names: OVITRELLE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Oocytes Retrieved | Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded. | Approximately 36 hours after hCG administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Metaphase II (MII) Oocytes | Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination. | Prior to insemination (within 6 hours after oocyte retrieval) | 
| Number of Fertilized (2 Pronuclei (2PN)) Oocytes | 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. | One day after oocyte retrieval | 
| Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate | 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. | 13-15 days after transfer | 
| Clinical Pregnancy Rate | Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer. | 5-6 weeks after transfer | 
| Frequency of Adverse Events (AEs) | The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented. | AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented | 
| Intensity of AEs | 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]). | AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented. |