Administration of GnRH Antagonist to Oocyte Donation Recipients

NCT00635258 | Completed DMC

• 1 other identifier: GnRH-ant.Ovodon
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Embryo Implantation

Keywords

GnRH antagonist; oocyte donation; pregnancy; implantation

Outcome Measures

Primary Outcomes (1)

• pregnancy and implantation rates

  "at 7 weeks"

Secondary Outcomes (1)

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

  "at 1 mounth"

Study Arms (2)

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-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)

Interventions

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.

Also known as: GnRH agonist

GnRH-a

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.

Also known as: GnRH antagonist

GnRH-ant

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with an indication for oocyte donation with functioning ovaries.

You may qualify if:

• 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.

Sponsors & Collaborators

• Centro Ginecologia y Obstetricia.: lead
• University of Valencia: collaborator

Study Sites (1)

CEGIOB

Valencia, Valencia, 46004, Spain

Location

Related Publications (5)

• Casan 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. doi: 10.1210/jcem.85.4.6503.

  PMID: 10770169 BACKGROUND

• Raga F, Casan 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. doi: 10.1210/endo.140.8.6899.

  PMID: 10433230 BACKGROUND

• Casan EM, Raga F, Polan ML. GnRH mRNA and protein expression in human preimplantation embryos. Mol Hum Reprod. 1999 Mar;5(3):234-9. doi: 10.1093/molehr/5.3.234.

  PMID: 10333357 BACKGROUND

• Raga F, Casan 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. doi: 10.1210/jcem.84.2.5464.

  PMID: 10022430 BACKGROUND

• Raga F, Casan 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. doi: 10.1095/biolreprod59.3.661.

  PMID: 9716567 BACKGROUND

MeSH Terms

Interventions

Triptorelin Pamoate; Gonadotropin-Releasing Hormone; ganirelix; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Raga Francisco, M.D., Ph.D.

  Centro Ginecologia y Obstetricia.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2008
• First Posted: March 13, 2008
• Study Start: January 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 13, 2008

Record last verified: 2008-03

Locations

ES (1)