ICSI vs IVF for Female Infertility

(SISTER Trial)

Overseen By Tasha Newsome

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Shady Grove Fertility Reproductive Science Center

Disqualifiers: Male infertility, ART contraindication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

95 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Kate Devine, MD

Principal Investigator

Shady Grove Fertility

Are You a Good Fit for This Trial?

This trial is for women facing infertility issues, without male fertility problems, who are undergoing in vitro fertilization (IVF). They must be willing to have their eggs divided and fertilized by two different methods using frozen donor sperm.

Inclusion Criteria

Absence of male factor infertility

Post-wash parameters: >50% motility, >5mil concentration

> 4 oocytes retrieved at time of transvaginal oocyte retrieval

Exclusion Criteria

We are using donor sperm due to significant male infertility issues.

I don't have any health issues that prevent me from taking antiretroviral therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Oocyte Retrieval and Insemination

Oocytes are retrieved and divided into two groups for insemination using ICSI and conventional IVF methods

1 week

1 visit (in-person)

Embryo Culture and Assessment

Embryos are cultured and assessed for fertilization, blastulation, and quality

1 week

Follow-up

Participants are monitored for early clinical pregnancy outcomes

5-7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Insemination (IVF)
• Intracytoplasmic Sperm Injection (ICSI)

Trial Overview The SISTER trial is testing whether intracytoplasmic sperm injection (ICSI) or conventional IVF leads to better embryo development with frozen donor sperm. It compares the number of usable embryos, rates of failed fertilization, embryo quality, and early pregnancy outcomes between the two methods.

How Is the Trial Designed?

Group I: Intracytoplasmic Sperm Injection (ICSI) Experimental Treatment 1 Intervention

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.

Group II: Conventional Insemination (IVF) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Shady Grove Fertility Reproductive Science Center

Lead Sponsor

Trials

7

Recruited

2,900+