D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: corifollitropin alfa

• Registration Number: NCT01633580
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

The purpose of the present study is to analyse if corifollitropin alfa, an agent for prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day 2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.

Detailed Description

Corifollitropin alfa is a new recombinant gonadotrophin with sustained follicle-stimulating activity. It offers novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF or in vitro fertilisation resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. Normally, this medication is started on day 2 of the cycle. In the present randomised trial, we want to evaluate whether this agent can be clinically used when started on day 4 of the cycle.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-06-29
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

Inclusion Criteria

• < 36 years old on day of randomisation
• FSH < 12 (in the early follicular phase)
• Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
• Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
• BMI ≤ 29
• Weight > 60 kg
• < 3 previous trials
• ICSI
• Randomisation at out-patient clinic

Exclusion Criteria

• ≥ 36 years old on day of randomisation
• Endometriosis ≥ grade 3
• PCOS
• Poor responders (development of < 4 follicles in a previous IVF/ICSI cycle)
• Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Day 2 group	corifollitropin alfa	Patients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol.
Day 4 group	corifollitropin alfa	Patients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa

Primary Outcome Measures

Name	Time	Method
Consumption of rFSH at the end of the follicular phase	up to 9 months	The purpose is to assess the additional need for recFSH in each treatment group

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	Up to 9 months	The purpose is to study the pregnancy rate in each treatment group

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Belgium