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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT04193358
Eligibility Criteria:
Inclusion Criteria:
* Male ≥ 20 years of age
* Attending the Department of Obstetrics and Gynecology of Farhat Hached University Hospital, Sousse, Tunisia, for consultation or semen analysis as part of infertility investigations
* Diagnosis of oligozoospermia (WHO 2010 definition)
* Diagnosis of Asthenozoospermia (WHO 2010 definition)
* Diagnosis of teratozoospermia1 (WHO 2010 definition)
* Diagnosis of idiopathic infertility
* Couple is candidate for Intrauterine Insemination (IUI), In Vitro Fertilization (IVF) and/or Intracytoplasmic Sperm Injection (ICSI).
Exclusion Criteria:
* Inclusion visit (prior to treatment initiation): Patients will be selected during this initial visit if they meet all inclusion and none of the exclusion criteria.
* Randomization visit: around 1-week post inclusion visit: Patients will be given either of study interventions.
* Follow up visit 1-month post treatment initiation: Patients will be given study interventions' refill for 1 month.
* Follow up visit 2-months post treatment initiation: Patients will be given study interventions' refill for another month.
* Follow up visit 3-months post treatment initiation: Patients will undergo laboratory assessment.
* Follow up visits every 3-months post Visit: Patients' female partner will undergo laboratory and clinical assessment.
* End of trial (CLOSING) visit 24-months post treatment initiation: Patients' female partner will undergo laboratory and clinical assessment.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT04193358
Study Brief:
Protocol Section:
NCT04193358