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Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days

NCT ID: NCT01093443

Last Updated: 2010-10-11

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-05-31

Brief Summary

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In this prospective study, the investigators would like to show whether ovarian stimulation with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle, is possible.

Detailed Description

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A recently accepted study demonstrated that raised progesterone levels can be normalized through administration of a GnRH antagonist during three subsequent days prior to the start of gonadotropin stimulation in a GnRH antagonist protocol. This regimen, after normalisation of the progesterone value, allows controlled ovarian hyperstimulation (COH). Since this regimen is valid in case of elevated progesterone, GnRH antagonists pretreatment may prove to be a valid tool for scheduling IVF treatment in patients with normal progesterone values on day 2 of the cycle. In this prospective randomised trial, the investigators study the impact of administration of a GnRH antagonist during 3 consecutive days at initiation 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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A

Patients undergo a standard treatment with a classical GnRH antagonist protocol.

Group Type PLACEBO_COMPARATOR

ovarian stimulation

Intervention Type DRUG

rFSH with GnRH antagonists

B

Before undergoing a standard protocol for ovarian stimulation, patients in this group receive a pretreatment with GnRH antagonists during 3 consecutive days

Group Type ACTIVE_COMPARATOR

ovarian stimulation

Intervention Type DRUG

GnRH antagonist, rFSH, GnRH antagonist

Interventions

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ovarian stimulation

rFSH with GnRH antagonists

Intervention Type DRUG

ovarian stimulation

GnRH antagonist, rFSH, GnRH antagonist

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \< 39 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 between 18 and 29 (both inclusive)
* 1st or 2nd trial
* IVF or ICSI
* Randomisation at out-patient clinic

Exclusion Criteria

* ≥ 39 years old on day of randomisation
* Endometriosis ≥ grade 3
* PCOS
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 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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Universitair Ziekenhuis Brussel

Locations

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UZ Brussel

Jette, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2009/196

Identifier Type: -

Identifier Source: org_study_id