Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Carmina Vidal, MD, Instituto Valenciano de Infertilidad, Spain

ClinicalTrials.gov Identifier:

NCT00633347

First received: February 21, 2008

Last updated: February 14, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 21, 2008
Last Updated Date	February 14, 2013
Start Date ^ICMJE	January 2007
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 10, 2008)	clinical pregnancy rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00633347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 10, 2008)	implantation rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Infertility
Intervention ^ICMJE	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
Study Arm (s)	Active Comparator: A A: Antagonist Interventions: Drug: Antagonist GnRH Cetrotide Drug: Agonist GnRH Acetate Triptoreline Active Comparator: B Agonist GnRH Intervention: Drug: Agonist GnRH Acetate Triptoreline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	570
Completion Date	October 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 44 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT00633347
Other Study ID Numbers ^ICMJE	VLC-CV-1006-02
Has Data Monitoring Committee	No
Responsible Party	Carmina Vidal, MD, Instituto Valenciano de Infertilidad, Spain
Study Sponsor ^ICMJE	Instituto Valenciano de Infertilidad, Spain
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Instituto Valenciano de Infertilidad, Spain
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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