A New Revolutionary 3-Injection- Protocol in Infertile Women

Study Overview
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Brief Summary
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This is a prospective randomised study of the evaluation of the clinical IVF results after following a new revolutionary 3-Injection- Protocol for controlled ovarian stimulation in infertile women.

Detailed Description
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A randomized prospective study focusing on infertile women undergoing ovarian stimulation for IVF, using Elonva (corifollitropin alfa) as part of two different stimulation protocols. Women assigned to Protocol A receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the evening of day 3 of the cycle, followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response). Women assigned to Protocol B are administered a single dose of Elonva (corifollitropin alfa) on day 2 of the cycle, followed by daily GnRH antagonist doses, fixed on day 7 of the cycle. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly. Live Birth Rates are estimated for both groups of patients. The number of the formed blastocysts in each group is measured, as well.

Official Title
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A New Revolutionary 3-Injection- Protocol in Infertile Women With a Single Long Acting GnRH Antagonist in the Luteal Phase, a Bolus Gonadotropin Injection in the Early Follicular Phase and a Single Triggering Dose.

Conditions
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Infertility, Female

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: primary infertility age 22-39 years; body mass index (BMI) 18-29kg/m2; regular menstrual cycle of 26-35 days, presumed to be ovulatory; 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 heart disease, QT prolongation, heart failure elevated liver enzymes, liver failure, hepatitis women with inflammatory or autoimmune disease abnormal karyotype polycystic ovarian syndrome endometriosis stage III/IV

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 39 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 |
| --- | --- |
| 3-Injection-Protocol Group<br>Women in group A (3-Injection-Protocol Group) receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the early follicular phase followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response). | Diagnostic Test: Live birth rate<br>* Live Birth Rate and Blastulation Rate according to the protocol of COS<br>* Other names: Blastulation rate;|
| Multiple-Injection- Protocol Group<br>Women assigned to group B (Multiple- Injection- Protocol Group) are administered a single dose of Elonva (corifollitropin alfa) in the early follicular phase followed by daily GnRH antagonist doses, either fixed on day 6 of the stimulation cycle, or when 2 or 3 follicles over 12-14 mm are present. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly. | Diagnostic Test: Live birth rate<br>* Live Birth Rate and Blastulation 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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IVF, infertility, long antagonist, long acting gonadotropin, corifollitropin alfa, ovarian stimulation