Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

NCT02046655 | Completed Phase 4

• 1 other identifier: UHR-11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Total number of retrieved oocytes

  36 h after human chorionic gonadotrophin (hCG) administration

Secondary Outcomes (2)

• 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

Study Arms (2)

Corifollitropin alfa group

EXPERIMENTAL

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

rec FSH group

ACTIVE COMPARATOR

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

Interventions

Corifollitropin alfa DRUG

Also known as: Elonva

Corifollitropin alfa group

rFSH DRUG

Also known as: Puregon

rec FSH group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• PGD or PGS
• TESE

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

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

Thessaloniki, Greece

Location

Related Publications (1)

• 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.

  PMID: 25492411 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; follitropin beta

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Efstratios M Kolibianakis, MD, MSc, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: January 28, 2014
• Study Start: January 1, 2011
• Primary Completion: March 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

GR (1)