Administration of GnRH Antagonist to Oocyte Donation Recipients

Pregnancy Clinical Trial

— GnRH-Ovodon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635258
• Other study ID #: GnRH-ant.Ovodon
• Status: Completed
• Phase: N/A
• First received: February 26, 2008
• Last updated: March 6, 2008
• Start date: January 2004
• Est. completion date: December 2007

Study information

• Verified date: March 2008
• Source: Centro Ginecologia y Obstetricia.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Embryo Implantation
• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	CEGIOB	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Centro Ginecologia y Obstetricia.	University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy and implantation rates		"at 7 weeks"	No
Secondary	age of the recipients, body mass index, days undergoing oestrogen therapy		"at 1 mounth"	No