Comparing ICSI versus conventional IVF using frozen third‑party donor sperm
Official title: Prospective Randomized Sibling-Oocyte Trial Comparing Fertilization and Embryo Development Outcomes Between Intracytoplasmic Sperm Injection (ICSI) and Conventional IVF Using Frozen Donor Sperm
Run by Shady Grove Fertility Reproductive Science Center · NCT07175571 · Data updated 2026-11-12
This trial tests whether injecting sperm into eggs (ICSI) or mixing eggs with frozen donor sperm (conventional IVF) makes more and better embryos for people using frozen donor sperm without male‑factor infertility.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 95 (estimated) |
| Sponsor | Shady Grove Fertility Reproductive Science Center Academic / other |
| Locations | 1 site (Rockville, Maryland) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | April 1, 2026 |
| Study ends | May 1, 2026 |
| Registry record updated | September 16, 2025 |
| Trial ID | NCT07175571 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People undergoing IVF with frozen donor sperm who have normal ovarian reserve, no male‑factor infertility, and are expected to produce more than four oocytes are ideal candidates.
✕Probably not a fit
Patients with male‑factor infertility, those using partner sperm, people with low ovarian reserve, or those unlikely to produce at least four oocytes are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized sibling‑oocyte trial in which each participant's retrieved eggs are split and randomly assigned to either ICSI or conventional IVF using cryopreserved donor sperm. The within‑patient design reduces variability from individual egg and ovarian differences and allows direct comparison of fertilization techniques. Primary outcomes include number of usable blastocysts and incidence of total fertilization failure, with secondary outcomes of embryo quality and early pregnancy rates. The trial is conducted at a single center with participants required to have normal ovarian reserve and more than four oocytes retrieved.
Why it matters
Potential benefit: If successful, the trial could identify which fertilization method yields more usable embryos from frozen donor sperm, helping clinicians choose the simpler or safer approach and potentially avoiding unnecessary ICSI.
How similar studies have gone: Retrospective studies and meta‑analyses suggest ICSI may reduce total fertilization failure but do not consistently show improved blastulation or pregnancy in non‑male factor cycles, and randomized sibling‑oocyte data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients undergoing IVF with frozen donor sperm at Shady Grove Fertility Center * Normal ovarian reserve (AMH \> 1 ng/mL, AFC \> 10) * Absence of male factor infertility * Post-wash parameters: \>50% motility, \>5mil concentration * \> 4 oocytes retrieved at time of transvaginal oocyte retrieval Exclusion Criteria: * Donor Sperm with significant male factor infertility (e.g., abnormal sperm concentration, motility, or morphology) * Any medical condition contraindicating ART
Where it's running
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Shady Grove Fertility Rockville
Rockville, Maryland, United States Recruiting
Study contacts
- Study coordinator: Allison Eubanks, MD
- Email: Allison.Eubanks@sgfertility.com
- Phone: 301-400-2432
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.