Recruiting

ICSI & IVFSISTER: Sibling Oocyte Insemination With Frozen Sperm From Third Party Donors: Evaluation of Reproductive Techniques

Sponsor:

Shady Grove Fertility Reproductive Science Center

Code:

NCT07175571

Conditions

Infertility, Female

Reproductive Techniques, Assisted

Fertilization in Vitro

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Intracytoplasmic Sperm Injection (ICSI)

Conventional Insemination (IVF)

Study Details

Brief 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.

Conditions

Infertility, Female

Reproductive Techniques, Assisted

Fertilization in Vitro

Study ID

NCT07175571

Start date

Sep 15, 2025

Status verified date

May, 2025

Completion date

May 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

95 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Intracytoplasmic Sperm Injection (ICSI)

Mature oocytes are injected with a single frozen-thawed donor sperm cell using micromanipulation under a microscope. This fertilization method is performed shortly after oocyte retrieval. Sperm used are pre-screened and standardized for post-thaw motility and morphology. ICSI is conducted in accordance with standard embryology lab protocols. The oocyte allocation to ICSI is randomized within each participant's cycle.

Conventional Insemination (IVF)

Oocytes are inseminated by co-incubation with frozen-thawed donor sperm in a culture dish for 16-18 hours. Sperm are washed and prepared according to lab protocol to ensure motility and concentration suitability. This method does not involve direct sperm injection. Oocytes are randomly assigned to this method within each participant's retrieved cohort.

Primary outcome measure

Blastulation Rate [ Time Frame: Day 5 to Day 7 post-insemination ]

Central Contacts and Locations

Central contacts

Allison Eubanks, MD

301-400-2432 Allison.Eubanks@sgfertility.com

Tasha Newsome

3015451289 Tasha.Newsome@sgfertility.com

Locations

Shady Grove Fertility Rockville

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Tasha Newsome

301-545-1289 Tasha.Newsome@sgfertility.com

Principal Investigator:

Phillip Romanski, MD

More Information

Sponsor

Shady Grove Fertility Reproductive Science Center

Last update posted

Sep 16, 2025

Last verified

May, 2025

Keywords

Intracytoplasmic Sperm Injection (ICSI)
Conventional IVF
Frozen Donor Sperm
Sibling-Oocyte Design
Non-Male Factor Infertility
Blastulation Rate
Total Fertilization Failure (TFF)
Fertilization Outcomes
Embryo Quality
Clinical Pregnancy Rate
Assisted Reproductive Technology (ART)
Embryo Development
In Vitro Fertilization
Oocyte Randomization
Female Infertility
Cryopreserved Sperm
Randomized Controlled Trial (RCT)
Reproductive Medicine
Fertility Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shady Grove Fertility Reproductive Science Center on 2025-09-16.