Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders

Phase 2

Completed

• Conditions: Infertility; Poor Ovarian Response
• Interventions: Drug: Triptorelin; Drug: Corifollitropin alfa 150μg; Drug: hpHMG

• Registration Number: NCT01732094
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

The purpose of the present study is to examine the level of ovarian response and the pregnancy rates among poor ovarian responders treated with a novel treatment protocol with 150μg corifollitropin alfa followed by 300IU hMG in a long GnRH agonist protocol.

Detailed Description

Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after injection , a time interval which is significantly shorter as compared to treatment with rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration may result in a significantly higher exposure of the small antral follicles to constant high levels of FSH during the early follicular phase, securing not only the recruitment of the follicles, but also the continued growth.

In the current study the investigators examine whether administration of corifollitropin followed by 300IU hMG in a long GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-11-17
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-22
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

Patients should fulfill the "Bologna criteria" for poor ovarian response

At least two of the following three features must be present:

i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC <7 follicles or AMH <1.1 ng/ml).

Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT (ovarian reserve test).

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Corifollitropin Alfa + hMG	Triptorelin	-
Corifollitropin Alfa + hMG	Corifollitropin alfa 150μg	-
Corifollitropin Alfa + hMG	hpHMG	-

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	10 to 12 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	Day of oocyte retrieval
Cycles with oocyte retrieval	Day of oocyte retrieval
Cycles with embryo transfer	Day of Embryo transfer

Trial Locations

Locations (1)

Centre for Reproductive Medicine UZ Brussel; 🇧🇪 Brussels, Belgium