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 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT01417195
Eligibility Criteria:
Main Inclusion Criteria:
* Infertile pre-menopausal female subjects
* Documented history of infertility (eg., unable to conceive for at least 1 year, or 6 months for women ≥36 years of age, or women with bilateral tubal occlusion or absence, or subjects who require donor sperm).
* Subject's male partner with semen analysis that was at least adequate for intracytoplasmic sperm injection (ICSI) within 6 months prior to the subjects beginning down-regulation with gonadotropin-releasing hormone (GnRH)-agonist. Partners with severe male factor requiring invasive or surgical sperm retrieval or donor sperm could have been used.
* Anti-mullerian hormone (AMH) \> 1 ng/mL and \< 3 ng/mL at screening.
* Eligible for in-vitro fertilisation (IVF) or ICSI treatment.
Main Exclusion Criteria:
* Oocyte donor or embryo recipient; gestational or surrogate carrier
* Previous IVF or assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response was defined as development of ≤ 2 mature follicles or history of 2 previous failed cycle cancellations prior to oocyte retrieval due to poor response.
* Inadequate number of oocytes, defined as fewer than 5 oocytes retrieved in previous ART attempts.
* Subject's male partners with obvious leukospermia (\>2 million white blood cells \[WBC\]/mL) or signs of infection in semen sample within 2 months of the start of subject's pituitary down-regulation. If either of these conditions existed, the male was to be treated with antibiotics and retested prior to subject's pituitary down-regulation.
* Undergoing blastomere biopsy and other experimental ART procedures.
* Body mass index (BMI) of ≤18 and ≥32 kg/m\^2
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
42 Years
Study:
NCT01417195
Study Brief:
Protocol Section:
NCT01417195