Long Antagonist Protocol for IVF: a Proof of Concept for a Single Luteal GnRH- Antagonist Protocol
Overview
- Phase
- Phase 3
- Intervention
- Degarelix
- Conditions
- Pregnancy, Ovarian
- Sponsor
- Assisting Nature
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- LH levels
- Last Updated
- 5 years ago
Overview
Brief Summary
A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF
Detailed Description
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.
Investigators
Papanikolaou Evaggelos
Papanikolaou Evaggelos, MD, PhD
Assisting Nature
Eligibility Criteria
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.
Arms & Interventions
Deg-24mg
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.
Intervention: Degarelix
Deg-16mg
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.
Intervention: Degarelix
Deg-12mg
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.
Intervention: Degarelix
Outcomes
Primary Outcomes
LH levels
Time Frame: 4 days after injection of Degarelix
Effectively down regulation of follicular LH levels (\<14mIU/ml)/