Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix

Study Overview
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Brief Summary
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A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF

Detailed Description
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A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF:Single dose of Degarelix 24mg, 16mg and 12 mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels. ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels. On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.

Official Title
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Long Antagonist Protocol for IVF: a Proof of Concept for a Single Luteal GnRH- Antagonist Protocol

Conditions
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Pregnancy, Ovarian

Intervention / Treatment
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* Drug: Degarelix


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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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: Deg-24mg<br>Single dose of Degarelix 24mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels. ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels. On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. | Drug: Degarelix<br>* Degarelix 24mg Degarelix 16mg Degarelix 12mg Active Comparator: Down regulation of LH, during exposing in three different doses of Degarelix<br>|
| Active Comparator: Deg-16mg<br>Single dose of Degarelix 16mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels. ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels. On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. | Drug: Degarelix<br>* Degarelix 24mg Degarelix 16mg Degarelix 12mg Active Comparator: Down regulation of LH, during exposing in three different doses of Degarelix<br>|
| Active Comparator: Deg-12mg<br>Single dose of Degarelix 12mg, on day 24th of previous luteal face cycle.On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels. ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels. On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. | Drug: Degarelix<br>* Degarelix 24mg Degarelix 16mg Degarelix 12mg Active Comparator: Down regulation of LH, during exposing in three different doses of Degarelix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LH levels | Effectively down regulation of follicular LH levels (<14mIU/ml)/ | 4 days after injection of Degarelix |