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Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days

This study has been completed.
Information provided by:
Universitair Ziekenhuis Brussel Identifier:
First received: March 24, 2010
Last updated: October 8, 2010
Last verified: November 2009
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.

Condition Intervention Phase
Drug: ovarian stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Administration of a GnRH Antagonist During 3 Days at Initiation of the Cycle: Impact on the Stimulation in IVF/ICSI

Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Endocrine profile [ Time Frame: up to 9 months ]
    The purpose is to assess the endocrine profile in each treatment group

Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: up to 9 months ]
    The purpose is to study the pregnancy rate in each treatment group

Enrollment: 70
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
Patients undergo a standard treatment with a classical GnRH antagonist protocol.
Drug: ovarian stimulation
rFSH with GnRH antagonists
Active Comparator: B
Before undergoing a standard protocol for ovarian stimulation, patients in this group receive a pretreatment with GnRH antagonists during 3 consecutive days
Drug: ovarian stimulation
GnRH antagonist, rFSH, GnRH antagonist

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.

Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01093443

UZ Brussel
Jette, Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
  More Information

Responsible Party: Paul Devroey, Universitair Ziekenhuis Brussel Identifier: NCT01093443     History of Changes
Other Study ID Numbers: 2009/196
Study First Received: March 24, 2010
Last Updated: October 8, 2010

Keywords provided by Universitair Ziekenhuis Brussel:
GnRH antagonist

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on April 27, 2017