A phase IIIb randomized open-label study to compare between IVF/ICSI outcomes two regimen of Cetrotide 0.25 mg used from Day 1 or from Day 7 of the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in ART. - ATTAC-PCO Study
- Conditions
- ?Prevention of premature ovulation in polycystic ovarian women undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
- Registration Number
- EUCTR2007-007932-25-FR
- Lead Sponsor
- Merck Lipha Santé
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
-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 (< 10 IU/L) and AMH 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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>To assess by ultrasound scans (US) the follicular development induced by Cetrotidein A and B Groups<br>To assess biological and clinical outcomes induced by Cetrotide in A and B Groups<br>To monitor safety of Cetrotide in A and B Groups<br>;Primary end point(s): Estradiol (E2) level on the releasing day (day of r-hCG administration) in A and B Groups.
- Secondary Outcome Measures
Name Time Method