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Administration of GnRH Antagonist to Oocyte Donation Recipients (GnRH-Ovodon)

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ClinicalTrials.gov Identifier: NCT00635258
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : March 13, 2008
Sponsor:
Collaborator:
University of Valencia
Information provided by:
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.

Condition or disease Intervention/treatment
Pregnancy Embryo Implantation Drug: triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) Drug: GnRH antagonist (Orgalutran®)

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Administration of GnRH Antagonist to Oocyte Donation Recipients During Endometrial Preparation.
Study Start Date : January 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
GnRH-ant
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®)
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 Name: GnRH antagonist

GnRH-a
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)
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 Name: GnRH agonist




Primary Outcome Measures :
  1. pregnancy and implantation rates [ Time Frame: "at 7 weeks" ]

Secondary Outcome Measures :
  1. age of the recipients, body mass index, days undergoing oestrogen therapy [ Time Frame: "at 1 mounth" ]


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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with an indication for oocyte donation with functioning ovaries.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635258


Locations
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Spain
CEGIOB
Valencia, Spain, 46004
Sponsors and Collaborators
Centro Ginecologia y Obstetricia.
University of Valencia
Investigators
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Principal Investigator: Raga Francisco, M.D., Ph.D. Centro Ginecologia y Obstetricia.
Publications:
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Responsible Party: Fernando Bonilla-Musoles, CEGIOB
ClinicalTrials.gov Identifier: NCT00635258    
Other Study ID Numbers: GnRH-ant.Ovodon
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008
Keywords provided by Centro Ginecologia y Obstetricia.:
GnRH antagonist
oocyte donation
pregnancy
implantation
Additional relevant MeSH terms:
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Triptorelin Pamoate
Ganirelix
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists