Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation

Study Description

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Brief Summary:

Oocyte donation is a well established procedure in assisted reproduction treatments (ART). It is demonstrated that the use of hormonal substitution therapy, for the synchronization of the cycles between the recipients and the donors, provides good results, similar to the ones obtained with the natural cycle. In the patients - recipients with preserved ovarian function, the recipient's natural cycle is annulled, thus preventing the spontaneous Luteinizing Hormone surge. Simultaneously and while waiting for the suitable donor, her endometrium is prepared. When the donation occurs and fertilization with the husband sperm takes place, her cycle is stimulated again in order to synchronize her window of implantation with the donor's ovulation.

Two different medications are commonly used to inhibit spontaneous ovulation: either GnRHa agonist or GnRH antagonists. The present study consists of the comparison between the single dose GnRH agonist (Decapeptyl 3,75 IM) and the 7 day dosage of GnRH antagonist (Cetrotide 0,25 mg). The administration of GnRHa is used fundamentally as a long liberation formulation, administered in a single intramuscular injection (IM), which is more practical in terms of use. Nevertheless, the unnecessary persistence and the potentially unfavorable action of GnRHa during the luteal phase and early gestation have questioned its use. The recovery of the Hypophysarian function begins only 8 weeks after the single injection of long liberation of triptorelina 3.75 mg. The GnRH antagonist (Cetrotide 0,25 mg) makes the hypofisary inhibition shorter than with the analogues and can prepare similar endometrium characteristics as a natural cycle. The recipients will be assigned randomly to a group of treatment or another.

Condition or disease	Intervention/treatment	Phase
Infertility	Drug: Antagonist GnRH Cetrotide; Drug: Agonist GnRH Acetate Triptoreline	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	570 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	January 2007
Actual Primary Completion Date :	October 2009
Actual Study Completion Date :	October 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: A; A: Antagonist	Drug: Antagonist GnRH Cetrotide; Cetrotide 0.25 mg. daily/ 7 days Drug: Agonist GnRH Acetate Triptoreline; Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose
Active Comparator: B; Agonist GnRH	Drug: Agonist GnRH Acetate Triptoreline; Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose

Outcome Measures

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Primary Outcome Measures :

1. clinical pregnancy rate [ Time Frame: 1 month ]

Secondary Outcome Measures :

1. implantation rate [ Time Frame: 1 month ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 44 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• infertile females with preserved gonadal function
• ages 18 - 43 years old

Exclusion Criteria:

• BMI: > 28
• recurrent miscarriages
• severe male factor
• important miomas
• > 44 years old

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Spain
IVI Valencia
Valencia, Spain, 46015

Sponsors and Collaborators

Instituto Valenciano de Infertilidad, IVI VALENCIA

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Carmina Vidal, MD, Gynaecologist IVI valencia; Principal Investigator, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:	NCT00633347 History of Changes
Other Study ID Numbers:	VLC-CV-1006-02
First Posted:	March 12, 2008
Last Update Posted:	February 15, 2013
Last Verified:	February 2013

Keywords provided by Carmina Vidal, MD, Instituto Valenciano de Infertilidad, Spain:

oocyte donation; endometrial preparation

Additional relevant MeSH terms:

Infertility; Genital Diseases, Male; Genital Diseases, Female; Prolactin Release-Inhibiting Factors; Cetrorelix; Hormones	Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Fertility Agents, Female; Fertility Agents; Reproductive Control Agents; Hormone Antagonists