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OpenTrials
Completed

NCT Number: NCT01633580

D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

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.

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Key information

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UZ Brussel

Jette, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Corifollitropin alfa

Drug

long acting FSH

Primary outcomes

  1. Consumption of rFSH at the end of the follicular phase

    Time frame: up to 9 months

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

Secondary outcomes

  1. Pregnancy rate

    Time frame: Up to 9 months

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

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 4, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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