Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation

NCT00633347 | Completed Phase 4

• 1 other identifier: VLC-CV-1006-02
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

oocyte donation; endometrial preparation

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  1 month

Secondary Outcomes (1)

• implantation rate

  1 month

Study Arms (2)

A

ACTIVE COMPARATOR

A: Antagonist

Drug: Antagonist GnRH Cetrotide; Drug: Agonist GnRH Acetate Triptoreline

B

ACTIVE COMPARATOR

Agonist GnRH

Drug: Agonist GnRH Acetate Triptoreline

Interventions

Antagonist GnRH Cetrotide DRUG

Cetrotide 0.25 mg. daily/ 7 days

A

Agonist GnRH Acetate Triptoreline DRUG

Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose

A; B

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

IVI Valencia

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynaecologist IVI valencia; Principal Investigator

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: March 12, 2008
• Study Start: January 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

ES (1)