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Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00633347
First Posted: March 12, 2008
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Carmina Vidal, MD, Instituto Valenciano de Infertilidad, Spain
  Purpose

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 Intervention Phase
Infertility Drug: Antagonist GnRH Cetrotide Drug: Agonist GnRH Acetate Triptoreline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Carmina Vidal, MD, Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • implantation rate [ Time Frame: 1 month ]

Enrollment: 570
Study Start Date: January 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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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, Spain
ClinicalTrials.gov Identifier: NCT00633347     History of Changes
Other Study ID Numbers: VLC-CV-1006-02
First Submitted: February 21, 2008
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