Prospective Randomized Sibling-Oocyte Trial Comparing Fertilization and Embryo Development Outcomes Between Intracytoplasmic Sperm Injection (ICSI) and Conventional IVF Using Frozen Donor Sperm

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
Shady Grove Fertility Rockville
RECRUITING
Rockville
Contact Information
Primary
Allison Eubanks, MD
Allison.Eubanks@sgfertility.com
301-400-2432
Backup
Tasha Newsome
Tasha.Newsome@sgfertility.com
3015451289
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 95
Treatments
Experimental: Intracytoplasmic Sperm Injection (ICSI)
In this arm, a portion of each participant's mature oocytes will be inseminated using intracytoplasmic sperm injection (ICSI). A single frozen-thawed donor sperm cell will be injected directly into each oocyte using micromanipulation techniques. The oocyte assignment to ICSI will be determined through randomized sibling-oocyte allocation. Embryos will be cultured under standard laboratory conditions and assessed for fertilization (2PN), blastulation, embryo quality, and early clinical pregnancy outcomes.
Experimental: Conventional Insemination (IVF)
In this arm, a portion of each participant's oocytes will be inseminated using the conventional in vitro fertilization (IVF) method. Frozen-thawed donor sperm with normal post-thaw parameters will be co-incubated with oocytes in culture media for fertilization. The oocyte assignment to this method will be determined through randomized sibling-oocyte allocation. Embryos will be cultured under the same laboratory conditions and assessed for fertilization (2PN), blastulation, embryo quality, and early clinical pregnancy outcomes.
Related Therapeutic Areas
Sponsors
Leads: Shady Grove Fertility Reproductive Science Center

This content was sourced from clinicaltrials.gov