SISTER: Sibling Oocyte Insemination With Frozen Sperm From Third Party Donors: Evaluation of Reproductive Techniques (NCT07175571)
Prospective Randomized Sibling-Oocyte Trial Comparing Fertilization and Embryo Development Outcomes Between Intracytoplasmic Sperm Injection (ICSI) and Conventional IVF Using Frozen Donor Sperm
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to learn whether two different methods of helping eggs and sperm join-intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF)-lead to better embryo development when using frozen donor sperm in people who do not have male fertility problems. The main questions it aims to answer are: Does one method create more usable embryos (blastocysts) than the other? Is there a difference in how often fertilization does not happen at all? Do either of the methods lead to better embryo quality or early pregnancy? Participants will: Have their eggs divided into two groups. One group will be fertilized using ICSI (where a sperm is injected directly into an egg), and the other using conventional IVF (where eggs are mixed with sperm in a dish). The fertilization method for each egg will be randomly assigned, with a random process also used to determine the assignment of any extra egg when an odd number is collected. Continue regular fertility treatment while the study team compares the results of each fertilization method. This study includes people with non-male factor infertility and uses frozen donor sperm. It hopes to learn whether ICSI, which is often used even when it may not be needed, truly helps improve outcomes compared to conventional IVF in these cases.
Who can join: Review the eligibility criteria below.
Location: Shady Grove Fertility Rockville — Rockville, Maryland
🧪 Interventions in This Study
- Intracytoplasmic Sperm Injection (ICSI) (PROCEDURE)
- Conventional Insemination (IVF) (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Shady Grove Fertility Rockville — Rockville, Maryland
📞 Contact the Study Coordinator
Phone: (301) 400-2432
Email: Allison.Eubanks@sgfertility.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.