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D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

NCT ID: NCT01633580

Last Updated: 2014-12-03

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

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Day 2 group

Patients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol.

Group Type PLACEBO_COMPARATOR

corifollitropin alfa

Intervention Type DRUG

long acting FSH

Day 4 group

Patients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa

Group Type ACTIVE_COMPARATOR

corifollitropin alfa

Intervention Type DRUG

long acting FSH

Interventions

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corifollitropin alfa

long acting FSH

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Blockeel Christophe

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZ Brussel

Jette, , Belgium

Site Status

Countries

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Belgium

References

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Blockeel C, Polyzos NP, Derksen L, De Brucker M, Vloeberghs V, van de Vijver A, De Vos M, Tournaye H. Administration of corifollitropin alfa on Day 2 versus Day 4 of the cycle in a GnRH antagonist protocol: a randomized controlled pilot study. Hum Reprod. 2014 Jul;29(7):1500-7. doi: 10.1093/humrep/deu105. Epub 2014 May 9.

Reference Type DERIVED
PMID: 24813196 (View on PubMed)

Other Identifiers

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2012/019

Identifier Type: -

Identifier Source: org_study_id