D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

Universitair Ziekenhuis Brussel67 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Infertility

Interventions

corifollitropin alfaDRUG

long acting FSH

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 36 Years

Medical Language ↔ Plain English

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)

Locations (1)

UZ Brussel

Jette, Belgium

Outcomes

Primary Outcomes

Consumption of rFSH at the end of the follicular phase

The purpose is to assess the additional need for recFSH in each treatment group

Time frame: up to 9 months

Secondary Outcomes

Pregnancy rate

The purpose is to study the pregnancy rate in each treatment group

Time frame: Up to 9 months

Data from ClinicalTrials.gov

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