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 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT01550861
Eligibility Criteria:
Inclusion Criteria:
1. Each subject must be female.
2. Each subject must have an indication for COH and IVF with or without ICSI.
3. Each subject must be willing and able to provide written informed consent for the trial
4. Each subject must be 25 to ≤42 years of age at the time of signing informed consent.
5. Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou \[PAP\] I or II) obtained within 12 months prior to signing informed consent must be available
Exclusion Criteria:
1. Subject with premature ovarian failure
2. Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction
3. Subject with malformation or absence of uterus
4. Subject has tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid).
5. Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
42 Years
Study:
NCT01550861
Study Brief:
Protocol Section:
NCT01550861