Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation

Study Overview
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Brief Summary
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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.

Conditions
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Infertility

Intervention / Treatment
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* Drug: Antagonist GnRH Cetrotide
* Drug: Agonist GnRH Acetate Triptoreline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>A: Antagonist | Drug: Antagonist GnRH Cetrotide<br>* Cetrotide 0.25 mg. daily/ 7 days<br>Drug: Agonist GnRH Acetate Triptoreline<br>* Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose<br>|
| Active Comparator: B<br>Agonist GnRH | Drug: Agonist GnRH Acetate Triptoreline<br>* Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oocyte donation, endometrial preparation