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?

This trial compares two methods to help eggs and sperm join: intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF). The researchers aim to determine which method produces more usable embryos and better embryo quality using frozen donor sperm. Women undergoing IVF at Shady Grove Fertility Center without male fertility issues may be suitable candidates. Participants will continue their regular fertility treatments while the study team evaluates which method is more effective. As an unphased trial, this study allows participants to contribute to important fertility research that could enhance future IVF outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems you can continue your regular fertility treatment while participating.

What prior data suggests that these methods are safe for embryo development?

Research has shown that both Intracytoplasmic Sperm Injection (ICSI) and conventional In Vitro Fertilization (IVF) are generally safe for fertility treatments. Over the past 25 years, studies have found that ICSI is well-tolerated and does not present major long-term safety issues. It often helps couples conceive, even without male fertility problems.

Conventional IVF is also a safe and widely used option worldwide. Specifically, one study found that pregnancy rates are similar between ICSI and conventional IVF for couples without male fertility issues. Both methods have been extensively used, and strong evidence supports their safety in humans. Participants can feel confident about the safety of these options when considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it directly compares two key techniques in assisted reproduction: Intracytoplasmic Sperm Injection (ICSI) and Conventional Insemination (IVF). Unlike traditional IVF, where sperm are mixed with the egg in a dish to allow fertilization, ICSI involves injecting a single sperm directly into an egg, which can be a game-changer for certain types of male infertility. By examining these methods side by side, the trial aims to provide clearer insights into which approach might lead to better fertilization rates, embryo quality, and pregnancy outcomes. Understanding these differences could significantly enhance treatment strategies for couples experiencing infertility.

What evidence suggests that this trial's treatments could be effective for female infertility?

This trial will compare Intracytoplasmic Sperm Injection (ICSI) with Conventional Insemination (IVF) for female infertility. Studies have shown that ICSI does not improve pregnancy outcomes compared to traditional IVF for couples without male fertility issues. Research even suggests that ICSI might result in fewer live births when only female fertility factors are present. In contrast, conventional IVF has been associated with higher pregnancy rates and more embryos available for transfer in these cases. Both ICSI and IVF are common fertility treatments, but evidence suggests that IVF might be the better option when male fertility problems are absent. ^{1 2 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11283721/

Intracytoplasmic sperm injection versus conventional in ... Conclusions. Compared with IVF, ICSI was associated with a reduction in live births when ART was indicated due to female-only factors.

2. academic.oup.com academic.oup.com/humrep/article/39/Supplement_1/deae108.220/7703357

O-187 Real-word data on effectiveness of ICSI over ... Based on logistic regression analysis, a significant reduction in live birth rate was demonstrated using ICSI compared to conventional IVF in ...

3. nature.com nature.com/articles/s41598-024-71744-1

The impact of intracytoplasmic sperm injection versus ... This study was aimed to investigate the impact of intracytoplasmic sperm injection (ICSI) on reproductive outcomes in couples with non-male factor infertility.

4. sciencedirect.com sciencedirect.com/science/article/pii/S266633412300106X

Comparing reproductive outcomes between conventional ... Nonindicated ICSI was associated with reduced blastocyst availability in fresh cycles compared with IVF, leading to lower live birth rates.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9572455/

Opportunities and Limits of Conventional IVF versus ICSI When available data were pooled together, pregnancy rate per cycle was 13.1% (n = 127/967) in c-IVF and 7.3% (n = 61/831) in ICSI cycles (p < 0.001). Live birth ...

6. asrm.org asrm.org/practice-guidance/practice-committee-documents/intracytoplasmic-sperm-injection-icsi-for-nonmale-factor-indications-a-committee-opinion-2020/

Intracytoplasmic sperm injection (ICSI) for non–male factor ... Additionally, this study reported similar clinical pregnancy rates with conventional insemination and ICSI (33% vs. 26%; RR 1.27; 95% CI, 0.95–1.72). The study ...

7. academic.oup.com academic.oup.com/humupd/article/30/2/174/7499718

IVF versus IUI with ovarian stimulation for unexplained infertility For the safety primary outcome, the rate of multiple pregnancy was not significantly lower in IVF than IUI-OS (3 RCTs, 890 women, 3.8% versus ...

8. fertstert.org fertstert.org/article/S0015-0282(23)00305-9/fulltext

Compared with conventional insemination, ... In the setting of nonmale factor infertility, ICSI resulted in a lower fertilization rate and an 11% lower embryo euploid rate compared with CI.