Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days

Universitair Ziekenhuis Brussel

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: ovarian stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01093443

2009/196

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

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

Treatment:

Drug: ovarian stimulation

Drug: ovarian stimulation

B

Active Comparator group

Description:

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

Treatment:

Drug: ovarian stimulation

Drug: ovarian stimulation