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OpenTrials
Completed

NCT Number: NCT00633347

Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation

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.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IVI Valencia

Valencia, 46015, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antagonist GnRH Cetrotide

Drug

Cetrotide 0.25 mg. daily/ 7 days

Agonist GnRH Acetate Triptoreline

Drug

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

Primary outcomes

  1. clinical pregnancy rate

    Time frame: 1 month

Secondary outcomes

  1. implantation rate

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 12, 2008
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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