Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol

NCT ID: NCT01732068

Last Updated: 2013-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-05-31

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 short 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 short GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"

Conditions

Infertility; Poor Ovarian Response

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Corifollitropin alfa+hMG

Group Type: EXPERIMENTAL

Triptorelin

Intervention Type: DRUG

Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards

Corifollitropin alfa

Intervention Type: DRUG

Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycle

hpHMG

Intervention Type: DRUG

300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering

Interventions

Triptorelin

Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards

Intervention Type: DRUG

Corifollitropin alfa

Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycle

Intervention Type: DRUG

hpHMG

300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering

Intervention Type: DRUG

Eligibility Criteria

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

-

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

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Nikolaos P. Polyzos

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikolaos P Polyzos, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

Centre for Reproductive Medicine UZ Brussel

Brussels, , Belgium

Countries

Belgium

Other Identifiers

2012/082

Identifier Type: -

Identifier Source: org_study_id