SISTER: Sibling Oocyte Insemination With Frozen Sperm From Third Party Donors: Evaluation of Reproductive Techniques

Part of paid clinical trials in Rockville, Maryland.

Sponsor
Shady Grove Fertility Reproductive Science Center
Study ID
NCT07175571
Status
Recruiting
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Conditions

  • Fertilization in Vitro
  • Infertility, Female
  • Reproductive Techniques, Assisted

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intracytoplasmic Sperm Injection (ICSI) — PROCEDURE
    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) — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Sep 15, 2025
Status verified
May 2025
Primary completion
Apr 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
95 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shady Grove Fertility RockvilleRockvilleMaryland20850
Tasha Newsome
[email protected]
301-545-1289
Allison Eubanks, MD (SUB_INVESTIGATOR)
Phillip Romanski, MD (PRINCIPAL_INVESTIGATOR)

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