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:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT03085433
Eligibility Criteria:
Inclusion Criteria:
* The target population includes couples planning in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI).
* Subjects with and without a history of prior IVF cycles will be included.
* All eligible couples where both partners are \>=18 years of age will be asked to join the study.
Exclusion Criteria:
* Male partner with severe oligoasthenospermia (concentration \< 5 x 10\^6 spermatozoa/mL; motility\< 10%)
* Female partner with anovulation (PCOS, FHA)
* Female partner age \>41
* Female partner AFC\< 7
* Female partner with obstructed fallopian tubes (assessed in all patients prior to IVF)
* Use of oocyte donor
* Either Partner:
* Cancer diagnosis in either partner
* Any significant disease or psychiatric disorder that would interfere with consenting process
* Treatment History:
o History of \>1 prior cycle cancellation due to poor response
* Treatment Plan:
* Embryo co-culture
* Use of adjunctive non-gonadotropin medications to improve embryo quality: growth hormone, sildenafil
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03085433
Study Brief:
Protocol Section:
NCT03085433