Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: ovarian stimulation; Drug: ovarian stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brussels
    • Jette, Brussels, Belgium, 1090
      • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: A; Patients undergo a standard treatment with a classical GnRH antagonist protocol.	Drug: ovarian stimulation; rFSH with GnRH antagonists; Drug: ovarian stimulation; GnRH antagonist, rFSH, GnRH antagonist
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; rFSH with GnRH antagonists; Drug: ovarian stimulation; GnRH antagonist, rFSH, GnRH antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endocrine profile	The purpose is to assess the endocrine profile in each treatment group	up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	The purpose is to study the pregnancy rate in each treatment group	up to 9 months

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (ESTIMATE): March 25, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2010
• Last Update Submitted That Met QC Criteria: October 8, 2010
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: IVF; GnRH antagonist; ICSI; pretreatment
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 2009/196