Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Subfertility

Treatments: Drug: Corifollitropin alfa; Drug: rFSH

Study type: Interventional

Funder types: Other

Identifiers

NCT02046655

UHR-11

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Corifollitropin alfa group

Experimental group

Description:

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.

Treatment:

Drug: Corifollitropin alfa

rec FSH group

Active Comparator group

Description:

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.

Treatment:

Drug: rFSH