Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Classical Antagonist Protocol

Study Overview
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Brief Summary
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A randomized prospective study of the evaluation of the clinical IVF results after following Long Antagonist protocol for controlled ovarian stimulation versus following classical antagonist protocol

Detailed Description
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A randomized prospective study of administration of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF: Single dose of Degarelix (24mg, 16mg or 12 mg), on day 24th of previous luteal face cycle, was administered. The Clinical Pregnancy and Live Birth Rates were estimated for this group of patients, comparing to the rates of the group which followed classical antagonist protocol. The number of the formed blastocysts in each group is measured, as well.

Official Title
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Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus Classical Antagonist Protocol

Conditions
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Pregnancy, Ovarian

Intervention / Treatment
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* Diagnostic Test: Pregnancy Rate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary infertility age 18-39 years; body mass index (BMI) 18-29kg/m2; regular menstrual cycle of 26-35days, 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; history of being a 'poor responder', defined as >20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe OHSS in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Long Antagonist Protocol<br>Clinical pregnancy rate and live birth rates of patients who followed Long Antagonist Protocol for COS | Diagnostic Test: Pregnancy Rate<br>* The clinical pregnancy and live birth rate according to the protocol of COS<br>|
| Classical Antagonist Protocol<br>Clinical pregnancy rate and live birth rates of patients who followed Classical Antagonist Protocol for COS | Diagnostic Test: Pregnancy Rate<br>* The clinical pregnancy and live birth rate according to the protocol of COS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rate according to stimulation protocol | Clinical Pregnancy Rate according to stimulation protocol | 6 weeks to 42 weeks after embryo transfer | 
| Number of formed blastocysts | The number of the formed blastocysts in each group | 5 days after the OPU day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth Rate according to stimulation protocol | Live Birth Rate according to stimulation protocol | 6 weeks to 42 weeks after embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long Antagonist, Classical Antagonist, live birth rate, clinical pregnancy rate, ovarian stimulation, IVF