Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reprodu⦠(NCT01185704) | Clinical Trial Compass
CompletedPhase 3
Analysis of Two Therapeutic With CetrotideĀ® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
France136 participantsStarted 2008-11
Plain-language summary
This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of CetrotideĀ® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted reproductive technology (ART).
Who can participate
Age range18 Years ā 35 Years
SexFEMALE
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Inclusion Criteria:
* Female subjects with PCO or Polycystic ovary syndrome (PCOS) according to the revised 2003 Rotterdam Consensus
* Female subjects suitable for IVF/ICSI, undergoing first or second attempt
* 18-35 years old, Body Mass Index (BMI) less than or equal to 32, non-smoking at least from Visit 0 (V0)
* Normal FSH value (less than 10 international unit per liter \[IU/L\]) on Day 3 of spontaneous cycle within 12 months prior to the trial
* Anti Mullerian Hormone (AMH) value (greater than 1.5 nanogram per milliliter \[ng/mL\]) of a spontaneous cycle within 12 months prior to the trial or at least at V0
* No history of active genito-urinary infection
* Normal thyroid function (or adequate substitution for at least 3 months)
* Negative cervical papanicolaou test within the last 12 months prior to study entry
* No gonadotropins, for at least one month prior to the trial
* No metformin therapy for at least one month prior to Visit 1 (V1)
* Subject who is able to participate in the trial and has provided written, informed consent.
Exclusion Criteria:
* Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term
* Drilling 3 months prior to V0
* Uterine malformation, diethylstilbestrol syndrome, synechia
* Female subjects with World Health Organization (WHO) Type I or III anovulation
* Female subjects with hyperprolactinemia
* Female subjects with more than 2 recurrent miscarriages (early or ā¦
What they're measuring
1
Estradiol (E2) Levels on r-hCG Day
Timeframe: r-hCG day (end of stimulation cycle [approximately 15 days])