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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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"

Conditions

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Infertility Poor Ovarian Response

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Corifollitropin Alfa + hMG

Group Type EXPERIMENTAL

Triptorelin

Intervention Type DRUG

Triptorelin 0.1 mg/1 ml solution daily from day 21 of the cycle onwards

Corifollitropin alfa 150μg

Intervention Type DRUG

Corifollitropin alfa 150μg (single dose) 2 or 3 weeks after initiation of triptorelin

hpHMG

Intervention Type DRUG

hpHMG 300IU daily from day 7 following Corifollitropin alfa onwards

Interventions

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Triptorelin

Triptorelin 0.1 mg/1 ml solution daily from day 21 of the cycle onwards

Intervention Type DRUG

Corifollitropin alfa 150μg

Corifollitropin alfa 150μg (single dose) 2 or 3 weeks after initiation of triptorelin

Intervention Type DRUG

hpHMG

hpHMG 300IU daily from day 7 following Corifollitropin alfa onwards

Intervention Type DRUG

Eligibility Criteria

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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).