Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT01185704
Eligibility Criteria:
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 late, and for any reasons)
* Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus, for subject or partner
* Abnormal gynecological bleeding of undetermined origin
* History of major thromboembolic disease
* Endometriosis (Grade III or IV)
* Presence or history of malignant tumors and related treatment
* Known case of tumors of the hypothalamus or pituitary gland
* Clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening
* Known allergic reaction or hypersensitivity to Cetrotide® or Ovitrelle®
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01185704
Study Brief:
Protocol Section:
NCT01185704