Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

Phase 4

Completed

• Conditions: Subfertility
• Interventions: Drug: rFSH; Drug: Corifollitropin alfa

• Registration Number: NCT02046655
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2014-01-24
• Study First Posted: 2014-01-28
• Primary Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Proven poor responders of couples with an indication for COS
2. ≥ 18 and < 45 years of age
3. BMI ≥ 18 and ≤ 32 kg/m2
4. Regular spontaneous menstrual cycle (24-35 days)
5. Availability of ejaculatory sperm (use of donated and/or cryo-preserved sperm is allowed)

Exclusion Criteria

1. PGD or PGS
2. TESE

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rec FSH group	rFSH	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.
Corifollitropin alfa group	Corifollitropin alfa	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.

Primary Outcome Measures

Name	Time	Method
Total number of retrieved oocytes	36 h after human chorionic gonadotrophin (hCG) administration

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece