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Completed

NCT Number: NCT00635258

Administration of GnRH Antagonist to Oocyte Donation Recipients

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.

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Key information

Age range

18 year–34 year

Sex eligibility

Female

Study type

Observational

Primary location

CEGIOB

Valencia, 46004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)

Drug

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.

Other names: GnRH agonist

GnRH antagonist (Orgalutran®)

Drug

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.

Other names: GnRH antagonist

Primary outcomes

  1. pregnancy and implantation rates

    Time frame: "at 7 weeks"

Secondary outcomes

  1. age of the recipients, body mass index, days undergoing oestrogen therapy

    Time frame: "at 1 mounth"

Sponsors and collaborators

Lead sponsor

Centro Ginecologia y Obstetricia.

Other

Collaborators

  • University of Valencia

Registry information

Official study title

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

Acronym: GnRH-Ovodon

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Mar 13, 2008
Registry last updated
Mar 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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