Clinical trial NCT00635258: Administration of GnRH Antagonist to Oocyte Donation Recipients
Official title: Administration of GnRH Antagonist to Oocyte Donation Recipients During Endometrial Preparation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Embryo Implantation
Keywords: GnRH antagonist
oocyte donation
pregnancy
implantation
Lead sponsor: Centro Ginecologia y Obstetricia.
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2008-03-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an indication for oocyte donation with functioning ovaries.

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.

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 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.

Primary outcomes:
measure: pregnancy and implantation rates
timeFrame: "at 7 weeks"
Secondary outcomes:
measure: age of the recipients, body mass index, days undergoing oestrogen therapy
timeFrame: "at 1 mounth"
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: CEGIOB
Study officials:
affiliation: Centro Ginecologia y Obstetricia.
name: Raga Francisco, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.