D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

Follicular Phase Endocrine Characteristics During Ovarian Stimulation and GnRH Antagonist Co-treatment for IVF; Randomized Trial Comparing Corifollitropin Alfa (Elonva) Initiated on Cycle Day 2 or 4.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01633580

Enrollment

Registered

2012-07-04

Start date

2011-12-31

Completion date

2013-03-31

Last updated

2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

ICSI, GnRH antagonist, corifollitropin alfa

Brief summary

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.

Detailed description

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.

Interventions

DRUGcorifollitropin alfa

long acting FSH

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 36 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Consumption of rFSH at the end of the follicular phase	up to 9 months	The purpose is to assess the additional need for recFSH in each treatment group

Secondary

Measure	Time frame	Description
Pregnancy rate	Up to 9 months	The purpose is to study the pregnancy rate in each treatment group

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026