?Prevention of premature ovulation in polycystic ovarian women undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
Conditions
Interventions
Trade Name: Cetrotide 0,25 mg poudre et solvant pour solution injectable
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Ovitrelle 250 microgrammes/0,5 ml solution inje
Sponsors
Merck Lipha Santé
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women with PCO or PCOS according to the revised 2003 Rotterdam Consensus - Suitable for IVF/ICSI, undergoing first or second attempt - 18-35 years old, Body Mass Index (BMI) ? 32, non smoking - Normal FSH value ( 1,5 ng/ml) on day 3 of spontaneous cycle within 3 months prior to the trial - No history of active genito-urinary infection - Normal thyroid function (or adequate substitution for at least 3 months). - Negative cervical Papanicolau test within the last 12 months prior to study entry. - No gonadotropins, for at least 3 months prior to the trial - No metformin therapy 1 month prior to the trial - Subject is willing and able to participate in the trial and has provided written, informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term - Uterine malformation, diethylstilbestrol syndrome, synechia - Women with WHO type I or III anovulation - Women with hyperprolactinemia - More than 2 recurrent miscarriages (early or late, and for any reasons) - Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus, for subject or partner - Abnormal gynaecological bleeding of undetermined origin - History of major thromboembolic disease - Endometriosis (grade III or IV) - Presence or history of malignant tumours and related treatment - Known case of tumours of the hypothalamus or pituitary gland - Clinically significant systemic disease or clinically significant abnormal haematology, chemistry, or urinalysis results at screening - Known allergic reaction or hypersensitivity to Cetrotide? or Ovid[t]rel[le]® - Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years - Participation in another clinical trial within 3 months prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the hormonal level changes on the releasing day (day of r-hCG administration) induced by Cetrotide 0.25 mg/d started on Day 1 (Goup A: D1) with Cetrotide 0.25 started on Day 7 (Goup B: D7) of the menstrual cycle (Day 0 (S0) or Day 6 (S6) of stimulation) in polycystic ovarian (PCO) subjects undergoing IVF/ICSI procedures.;Secondary Objective: To compare the hormonal changes during the stimulation induced by Cetrotide in A and B Groups To assess by ultrasound scans (US) the follicular development induced by Cetrotidein A and B Groups To assess biological and clinical outcomes induced by Cetrotide in A and B Groups To monitor safety of Cetrotide in A and B Groups ;Primary end point(s): Estradiol (E2) level on the releasing day (day of r-hCG administration) in A and B Groups. | — |
Countries
France
Outcome results
None listed