Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

NCT ID: NCT02046655

Last Updated: 2014-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31

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.

Conditions

Subfertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Corifollitropin alfa group

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.

Group Type: EXPERIMENTAL

Corifollitropin alfa

Intervention Type: DRUG

rec FSH group

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.

Group Type: ACTIVE_COMPARATOR

rFSH

Intervention Type: DRUG

Interventions

Corifollitropin alfa

Intervention Type: DRUG

rFSH

Intervention Type: DRUG

Other Intervention Names

Elonva; Puregon

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

E.M. Kolibianakis

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Efstratios M Kolibianakis, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki

Locations

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

Thessaloniki, , Greece

Countries

Greece

References

Kolibianakis EM, Venetis CA, Bosdou JK, Zepiridis L, Chatzimeletiou K, Makedos A, Masouridou S, Triantafillidis S, Mitsoli A, Tarlatzis BC. Corifollitropin alfa compared with follitropin beta in poor responders undergoing ICSI: a randomized controlled trial. Hum Reprod. 2015 Feb;30(2):432-40. doi: 10.1093/humrep/deu301. Epub 2014 Dec 9.

Reference Type: DERIVED

PMID: 25492411 (View on PubMed)

Other Identifiers

UHR-11

Identifier Type: -

Identifier Source: org_study_id