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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01093443

Enrollment

Registered

2010-03-25

Start date

2009-11-30

Completion date

2010-05-31

Last updated

2010-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

IVF, ICSI, GnRH antagonist, pretreatment

Brief 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.

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.

Interventions

DRUGovarian stimulation

rFSH with GnRH antagonists

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 39 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026