Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days

This study has been completed.
Sponsor:
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01093443
First received: March 24, 2010
Last updated: October 8, 2010
Last verified: November 2009
  Purpose

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
Infertility
Drug: ovarian stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Endocrine profile [ Time Frame: up to 9 months ] [ Designated as safety issue: No ]
    The purpose is to assess the endocrine profile in each treatment group


Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: up to 9 months ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093443

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

No publications provided

Responsible Party: Paul Devroey, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01093443     History of Changes
Other Study ID Numbers: 2009/196
Study First Received: March 24, 2010
Last Updated: October 8, 2010
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitair Ziekenhuis Brussel:
IVF
ICSI
GnRH antagonist
pretreatment

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014