Pregnancy, Ovarian
Conditions
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.
Interventions
DRUGDegarelix
Degarelix 24mg Degarelix 16mg Degarelix 12mg Active Comparator: Down regulation of LH, during exposing in three different doses of Degarelix
Sponsors
Assisting Nature
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LH levels | 4 days after injection of Degarelix | Effectively down regulation of follicular LH levels (\<14mIU/ml)/ |
Countries
Greece
Contacts
Primary ContactEvaggelos Papanikolaou, MD, PhD
Outcome results
None listed