Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation

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ClinicalTrials.gov Identifier: NCT00633347

Recruitment Status : Completed

First Posted : March 12, 2008

Last Update Posted : February 15, 2013

Sponsor:

Information provided by (Responsible Party):

Carmina Vidal, MD, Instituto Valenciano de Infertilidad, IVI VALENCIA

Study Description

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


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

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

Primary Outcome Measures :

clinical pregnancy rate [ Time Frame: 1 month ]

Secondary Outcome Measures :

implantation rate [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633347

Locations


Spain
IVI Valencia
Valencia, Spain, 46015

Sponsors and Collaborators

Instituto Valenciano de Infertilidad, IVI VALENCIA

More Information


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

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


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

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