Investigating how sperm origin affects embryo quality in male infertility
Can the Origin of Sperm - Ejaculated or Testicular- Affect Embryo Ploidy in Patients with Severe Male Factor Infertility?
NA · Ganin Fertility Center · NCT06476379
This study is trying to see if using sperm from ejaculation or from the testicles affects the quality of embryos in men with severe infertility.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Ganin Fertility Center (other) |
| Locations | 1 site (Cairo, Maadi) |
| Trial ID | NCT06476379 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the impact of sperm origin on embryo ploidy in patients with severe male factor infertility. It will compare outcomes of preimplantation genetic testing for aneuploidy (PGT-A) between embryos created using ejaculated sperm and those using testicular sperm extracted through TESE. The focus is on understanding how these different sperm sources influence the success of embryo transfers and overall clinical outcomes in assisted reproductive technology. The study will involve male patients diagnosed with severe infertility and their normo responder female partners.
Who should consider this trial
Good fit: Ideal candidates include males diagnosed with severe male factor infertility who are undergoing ICSI PGT-A cycles with normo responder female partners.
Not a fit: Patients with conditions such as leukocytospermia, varicocele, or known genetic abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve embryo selection processes and enhance pregnancy outcomes for couples facing male infertility.
How similar studies have performed: While there is some evidence suggesting sperm origin may influence embryo quality, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cases planned to have ICSI PGT-A cycles * Males diagnosed as severe male factor infertility * Normo responder female partners Exclusion Criteria: * Leukocytospermia * Presence of varicocele. * Known genetic abnormality * Use of sperm or oocyte donors * Use of gestational carrier * Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection * Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Where this trial is running
Cairo, Maadi
- Ganin Fertility Center — Cairo, Maadi, Egypt (RECRUITING)
Study contacts
- Principal investigator: Eman Hasanen — Ganin Fertility Center
- Study coordinator: Eman Hasanen
- Email: em.saberh@gmail.com
- Phone: 00201282012291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Male Infertility, ICSI, Male infertility, PGT-A, TESE