Single Follicular Dexarelix for LH Suppression During Ovarian Stimulation in Oocyte Donors.

Study Overview
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Brief Summary
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A randomized prospective study in the evaluation of the long acting GnRH antagonist Degarelix against the classical multidose regime with Ganirelix for LH suppression during the follicular phase of an ovarian stimulation cycle in oocyte donors.

Detailed Description
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A randomized prospective study of the use of single dose of the long acting GnRH antagonist Degarelix for ovarian stimulation cycle in oocyte donors: Ovarian stimulation started on cycle Day2 with gonadotropins 175-300 IU and either GnRH antagonist single dose Degarelix or multidose GnRH antagonist Ganirelix initiated on Day6 of the stimulation cycle. Agonist triggering was used in both groups for oocyte maturation. Blastocyst formation rate and Live Birth Rates were estimated for both groups.

Official Title
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Single Follicular Dexarelix, a New Long Acting GnRH- Antagonist for LH Suppression During Ovarian Stimulation in Oocyte Donors. A Randomised Control Trial.

Conditions
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Infertility, Premature Ovarian Failure

Intervention / Treatment
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* Diagnostic Test: live birth rate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 20-34 years; body mass index (BMI) 18-29kg/m2; regular menstrual cycle of 26-35 days, AMH levels age appropriate (≥2.3 ng/ml) early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l). Exclusion Criteria: women with diabetes and other metabolic disease women with hereditary genetic diseases; women with heart disease, QT prolongation,heart failure elevated liver enzymes, liver failure, hepatitis women with inflammatory or autoimmune disease abnormal karyotype; endometriosis stage III/IV; history of recurrent miscarriage; severe OHSS in a previous stimulation cycle or any contraindication for the use of gonadotrophins.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 34 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Dose antagonist Degarelix<br>The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with a single dose Degarelix. | Diagnostic Test: live birth rate<br>* The blastulation rate and live birth rate according to the protocol of COS<br>* Other names: blastulation rate;|
| Multidose antagonist Ganirelix<br>The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with multidose dose Ganirelix. | Diagnostic Test: live birth rate<br>* The blastulation rate and live birth rate according to the protocol of COS<br>* Other names: blastulation rate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate according to stimulation protocol | Live birth rate according to stimulation protocol | Up to 38 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastulation rate according to stimulation protocol | Blastulation rate according to stimulation protocol | Up to 6 days post oocyte retrieval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antagonist protocol, degarelix antagonist protocol, degarelix, IVF