Administration of GnRH Antagonist to Oocyte Donation Recipients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Administration of GnRH Antagonist to Oocyte Donation Recipients During Endometrial Preparation.

Conditions
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Pregnancy, Embryo Implantation

Intervention / Treatment
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* Drug: triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)
* Drug: GnRH antagonist (Orgalutran®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GnRH-ant<br>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. | Drug: GnRH antagonist (Orgalutran®)<br>* 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.<br>* Other names: GnRH antagonist;|
| GnRH-a<br>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. | Drug: triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)<br>* 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.<br>* Other names: GnRH agonist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy and implantation rates |  | at 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age of the recipients, body mass index, days undergoing oestrogen therapy |  | at 1 mounth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GnRH antagonist, oocyte donation, pregnancy, implantation