Administration of GnRH Antagonist to Oocyte Donation Recipients

Completed

• Conditions: Pregnancy; Embryo Implantation
• Interventions: Drug: GnRH antagonist (Orgalutran®); Drug: triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)

• Registration Number: NCT00635258
• Lead Sponsor: Centro Ginecologia y Obstetricia.

Brief Summary

This prospective and randomized study was performed to evaluate whether the replacement of GnRH agonist by a GnRH antagonist in oocyte donation recipients during endometrial preparation has any impact on pregnancy and implantation rates.

Detailed Description

This was a prospective and randomized study undertaken between January 2004 and December 2007. One hundred patients with an indication for oocyte donation with functioning ovaries and IVF with or without intracytoplasmatic sperm injection (ICSI) were recruited for the study. After assignment to IVF or IVF/ICSI randomization was performed to 1 of the 2 treatment groups (GnRH agonist or GnRH antagonist during endometrial preparation in oocyte donation recipients) using a computed-generated randomization schedule assigned via numbered sealed envelopes.

In our program, we used excess oocytes from IVF that were voluntarily donated by patients after informed consent.

The indications for oocyte donation were reduced ovarian reserve (59%), recurrent IVF failures (21%), premature ovarian failure (16%), and genetic anomaly (4%).

This study was performed according to the declaration of Helsinki and the European Community note on Good Clinical Practice for trials on medical products in the European Community (CPMP Working Party on Efficacy of Medical Products, 1990). Furthermore, the local ethics committee approved the study protocol, and written informed consent was obtained from all patients.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-02-26
• Status Verified: 2008-03
• Study First Submitted QC: 2008-03-06
• Last Update Submitted: 2008-03-06
• Study First Posted: 2008-03-13
• Last Update Posted: 2008-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Age between 18-34 years
• Body mass index between 19-30 kg/m2;
• History of regular menstrual cycles, ranging from 25-35 days
• No relevant systemic disease (all patients were screened for hepatitis B and C, human immunodeficiency viruses I and II, syphylis, and vaginal infection), genetic disease, severe endometriosis or pelvic inflamatory disease
• No more than two previous IVF cycles; and
• No previous IVF cycles with poor response (less than three oocytes in a previous IVF cycle) or severe ovarian hyperstimulation syndrome.

Exclusion Criteria

• Patients without inclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GnRH-ant	GnRH antagonist (Orgalutran®)	Patients were treated with a GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration.
GnRH-a	triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)	GnRH long protocol using 0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state. Furthermore, the triptorelin administration was maintained until the day of donor's hCG administration.

Primary Outcome Measures

Name	Time	Method
pregnancy and implantation rates	"at 7 weeks"

Secondary Outcome Measures

Name	Time	Method
age of the recipients, body mass index, days undergoing oestrogen therapy	"at 1 mounth"

Trial Locations

Locations (1)

CEGIOB; 🇪🇸 Valencia, Spain