Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation
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ClinicalTrials.gov Identifier: NCT00633347 |
Recruitment Status
:
Completed
First Posted
: March 12, 2008
Last Update Posted
: February 15, 2013
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Infertility | Drug: Antagonist GnRH Cetrotide Drug: Agonist GnRH Acetate Triptoreline | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 570 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | October 2009 |
Arm | Intervention/treatment |
---|---|
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
|
- clinical pregnancy rate [ Time Frame: 1 month ]
- implantation rate [ Time Frame: 1 month ]

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Ages Eligible for Study: | 18 Years to 44 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
Spain | |
IVI Valencia | |
Valencia, Spain, 46015 |
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 Posted: | March 12, 2008 Key Record Dates |
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 |