Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days

NCT01093443 — Phase 4, Completed, 70 participants, Universitair Ziekenhuis Brussel

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Administration of a GnRH Antagonist During 3 Days at Initiation of the Cycle: Impact on the Stimulation in IVF/ICSI

Registry	NCT01093443
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	70 (Actual)
Sponsor	Universitair Ziekenhuis Brussel (Other)
Conditions	Infertility
Interventions	ovarian stimulation (Drug)
Dates	start 2009-11-01, primary completion 2010-05-01, completion 2010-05-01, first posted 2010-03-25, last updated 2010-10-11
Locations	1 site in Belgium

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
A	Placebo comparator	Drug: ovarian stimulation	Patients undergo a standard treatment with a classical GnRH antagonist protocol.
B	Active comparator	Drug: ovarian stimulation	Before undergoing a standard protocol for ovarian stimulation, patients in this group receive a pretreatment with GnRH antagonists during 3 consecutive days

ovarian stimulation (Drug): rFSH with GnRH antagonists
ovarian stimulation (Drug): GnRH antagonist, rFSH, GnRH antagonist

+Outcome measures

Primary outcomes

Endocrine profile [up to 9 months]: The purpose is to assess the endocrine profile in each treatment group

Secondary outcomes

Pregnancy rate [up to 9 months]: The purpose is to study the pregnancy rate in each treatment group

+Eligibility

Sex: Female, ages: 18 Years to 39 Years

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

+Locations (1)

Facility	City	Country	Status
UZ Brussel	Jette, Brussels Capital	Belgium