Administration of GnRH Antagonist to Oocyte Donation Recipients - Full Text View

Sponsors and Collaborators:	Centro Ginecologia y Obstetricia. University of Valencia
Information provided by:	Centro Ginecologia y Obstetricia.
ClinicalTrials.gov Identifier:	NCT00635258

Purpose

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	Intervention
Pregnancy Embryo Implantation	Drug: triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) Drug: GnRH antagonist (Orgalutran®)

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Administration of GnRH Antagonist to Oocyte Donation Recipients During Endometrial Preparation.

Resource links provided by NLM:

Drug Information available for: Gonadorelin Gonadorelin hydrochloride Triptorelin Triptorelin pamoate Ganirelix Ganirelix acetate LH-RH

U.S. FDA Resources

Further study details as provided by Centro Ginecologia y Obstetricia.:

Primary Outcome Measures:

pregnancy and implantation rates [ Time Frame: "at 7 weeks" ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

age of the recipients, body mass index, days undergoing oestrogen therapy [ Time Frame: "at 1 mounth" ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	100
Study Start Date:	January 2004
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.
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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 34 Years
Genders 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635258

Locations

Spain
CEGIOB
Valencia, Spain, 46004

Sponsors and Collaborators

Centro Ginecologia y Obstetricia.

University of Valencia

Investigators

Principal Investigator:

Raga Francisco, M.D., Ph.D.

Centro Ginecologia y Obstetricia.

More Information

Publications:

Casañ EM, Raga F, Bonilla-Musoles F, Polan ML. Human oviductal gonadotropin-releasing hormone: possible implications in fertilization, early embryonic development, and implantation. J Clin Endocrinol Metab. 2000 Apr;85(4):1377-81.

Raga F, Casañ EM, Kruessel J, Wen Y, Bonilla-Musoles F, Polan ML. The role of gonadotropin-releasing hormone in murine preimplantation embryonic development. Endocrinology. 1999 Aug;140(8):3705-12.

Casañ EM, Raga F, Polan ML. GnRH mRNA and protein expression in human preimplantation embryos. Mol Hum Reprod. 1999 Mar;5(3):234-9.

Raga F, Casañ EM, Wen Y, Huang HY, Bonilla-Musoles F, Polan ML. Independent regulation of matrix metalloproteinase-9, tissue inhibitor of metalloproteinase-1 (TIMP-1), and TIMP-3 in human endometrial stromal cells by gonadotropin-releasing hormone: implications in early human implantation. J Clin Endocrinol Metab. 1999 Feb;84(2):636-42.

Raga F, Casañ EM, Kruessel JS, Wen Y, Huang HY, Nezhat C, Polan ML. Quantitative gonadotropin-releasing hormone gene expression and immunohistochemical localization in human endometrium throughout the menstrual cycle. Biol Reprod. 1998 Sep;59(3):661-9.

Responsible Party:	CEGIOB ( Fernando Bonilla-Musoles )
Study ID Numbers:	GnRH-ant.Ovodon
Study First Received:	February 26, 2008
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00635258 History of Changes
Health Authority:	Spain: Ethics Committee

Keywords provided by Centro Ginecologia y Obstetricia.:

GnRH antagonist
oocyte donation
pregnancy
implantation

Study placed in the following topic categories:

Deslorelin
Antineoplastic Agents, Hormonal
Ganirelix
Contraceptive Agents
Triptorelin

Hormone Antagonists
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female

Reproductive Control Agents
Luteolytic Agents
Pharmacologic Actions
Ganirelix
Triptorelin
Therapeutic Uses

ClinicalTrials.gov processed this record on September 10, 2009