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

Phase 2CompletedNCT01732068

Universitair Ziekenhuis Brussel51 enrolled

Overview

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.

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"

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infertility Poor Ovarian Response

Interventions

TriptorelinDRUG

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

Corifollitropin alfaDRUG

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

hpHMGDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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: \-

Locations (1)

Centre for Reproductive Medicine UZ Brussel

Brussels, Belgium

Outcomes

Primary Outcomes

Ongoing pregnancy rate

Time frame: 10 to 12 weeks of gestation

Secondary Outcomes

Number of oocytes retrieved

Time frame: Day of oocyte retrieval

Cycles with embryo transfer

Time frame: Day of Embryo transfer

Data from ClinicalTrials.gov

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