Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

Subfertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046655
• Other study ID #: UHR-11
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2013
• Last updated: May 13, 2014
• Start date: January 2011

Study information

• Verified date: May 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subfertility

Intervention

Drug:
• Corifollitropin alfa

• rFSH

Locations

Country	Name	City	State
Greece	Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of retrieved oocytes		36 h after human chorionic gonadotrophin (hCG) administration	No
Secondary	Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)		At 6-8 weeks of gestation	No
Secondary	Number of embryos transferred		2 days following oocyte retrieval	No