Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

Study Overview
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Brief Summary
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Corifollitropin alfa has been shown to result in significantly more oocytes compared to daily recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due to the higher circulating FSH activity during the first days of stimulation. For this reason, the use of corifollitropin alfa might be beneficial in poor responders in whom the number of oocytes retrieved is crucial for success. The purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment compared to daily recFSH in terms of the number of oocytes retrieved in a defined population of poor responder patients undergoing intracytoplasmic sperm injection (ICSI) using gonadotrophin releasing hormone (GnRH) antagonists.

Official Title
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Corifollitropin Alfa Compared to Daily Rec FSH in Poor Responders Undergoing ICSI Using a GnRH Antagonist Protocol

Conditions
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Subfertility

Intervention / Treatment
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* Drug: Corifollitropin alfa
* Drug: rFSH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proven poor responders of couples with an indication for COS ≥ 18 and < 45 years of age BMI ≥ 18 and ≤ 32 kg/m2 Regular spontaneous menstrual cycle (24-35 days) Availability of ejaculatory sperm (use of donated and/or cryo-preserved sperm is allowed) Exclusion Criteria: PGD or PGS TESE

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Corifollitropin alfa group<br>On day 2 of the cycle, a single subcutaneous (SC) dose of 150 μg Corifollitropin alfa (Elonva) will be administered. GnRH antagonist (Orgalutran) 0.25 mg/day flexible initiation by a follicle of 14mm. A daily dose of recFSH (450 IU/day) will be used from day 8 of stimulation until the day of hCG, if necessary. Triggering of final oocyte maturation will be performed using 250 μg of rechCG. | Drug: Corifollitropin alfa<br> <br> * Other names: Elonva;|
| Active Comparator: rec FSH group<br>On day 2 of the cycle, daily SC dose of min 450 IU recFSH (Puregon) will be administered. GnRH antagonist (Orgalutran) 0.25 mg/day , flexible initiation by a follicle of 14mm. Triggering of final oocyte maturation will be performed using 250 μg of rechCG. | Drug: rFSH<br> <br> * Other names: Puregon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of retrieved oocytes |  | 36 h after human chorionic gonadotrophin (hCG) administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation) |  | At 6-8 weeks of gestation | 
| Number of embryos transferred |  | 2 days following oocyte retrieval |