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:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT06990906
Eligibility Criteria:
Inclusion Criteria:
1. Couples intended to be ICSI recruited from the clinic's IVF units. Couples may be utilizing their own gametes, or gametes from one known donor (for donated gametes, the donor will also need to consent).
2. Male subject aged ≥ 21 years at the time of screening
3. Female subjects aged 21 to 42 years at the time of screening
4. Number of follicles ≥13 mm as measured by ultrasound evaluation at ovulation trigger is at least 11
5. The subject can provide a sperm sample by ejaculation. Sperm can be produced by electric ejaculation. Fresh or thawed sperm can be used for the procedure.
6. Total Motile sperm Count (TMC) \> 1 million
7. The subject can understand and sign a written informed consent form
Exclusion Criteria:
1. Severe grade IV endometriosis (suspected or confirmed by surgery), moderate to severe adenomyosis, or a condition that is known to render implantation unlikely, such as 3 or more prior losses related to uterine issues.
2. Sperm produced by TESE (testicular sperm extraction)/TESA (testicular sperm aspiration).
3. Frozen/thawed oocytes.
4. The subjects are under active oncology treatment.
5. Participation in another study with any investigational drug or device that may conflict with the objectives, follow-up, or testing of this study.
6. Planned sex selection or any other scenario where a less-optimal embryo is planned to be transferred
7. Anonymous donor or other donor scenarios where it is uncertain whether freely given consent can be obtained
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
42 Years
Study:
NCT06990906
Study Brief:
Protocol Section:
NCT06990906