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Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Antagonist GnRH Cetrotide
Agonist GnRH Acetate Triptoreline
Sponsored by
Instituto Valenciano de Infertilidad, IVI VALENCIA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring oocyte donation, endometrial preparation

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • IVI Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

A: Antagonist

Agonist GnRH

Outcomes

Primary Outcome Measures

clinical pregnancy rate

Secondary Outcome Measures

implantation rate

Full Information

First Posted
February 21, 2008
Last Updated
February 14, 2013
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
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1. Study Identification

Unique Protocol Identification Number
NCT00633347
Brief Title
Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
oocyte donation, endometrial preparation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
570 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
A: Antagonist
Arm Title
B
Arm Type
Active Comparator
Arm Description
Agonist GnRH
Intervention Type
Drug
Intervention Name(s)
Antagonist GnRH Cetrotide
Intervention Description
Cetrotide 0.25 mg. daily/ 7 days
Intervention Type
Drug
Intervention Name(s)
Agonist GnRH Acetate Triptoreline
Intervention Description
Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Time Frame
1 month
Secondary Outcome Measure Information:
Title
implantation rate
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
IVI Valencia
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

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Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation

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