Trial · Interventional
CompletedPhase 4Registry dataUse of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 570 participants (actual)
- Sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Spain
- Start
- Jan 2007
- Primary completion
- Oct 2009
- Completion
- Oct 2009
- First posted
- 12 Mar 2008 (estimated)
- Last update posted
- 15 Feb 2013 (estimated)
- Conditions
- Infertility
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation
NCT00633347Jan 2007 to Oct 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Antagonist GnRH CetrotideDrug
- Agonist GnRH Acetate TriptorelineDrug
Arms2
Active comparator
A
A: Antagonist
Active comparator
B
Agonist GnRH
Primary outcomes1
Outcomes the sponsor listed as primary.
clinical pregnancy rate
Time frame · 1 month
Secondary outcomes(1)
implantation rate
Time frame · 1 month
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 44 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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