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Two ways of fertilizing eggs with frozen donor sperm in female infertility

Compares ICSI with conventional IVF using frozen donor sperm in women with infertility.

Key facts

Who runs it
Shady Grove Fertility Reproductive Science Center
Where
Rockville, United StatesSee the site
Trial code
Registry title
SISTER: Sibling Oocyte Insemination With Frozen Sperm From Third Party Donors: Evaluation of Reproductive Techniques
Status
Recruiting
People taking part
95 people, planned
Started
15 Sept 2025
Planned end
1 May 2026
Type of study
Interventional, 2 groups
Treatments tested
  • Intracytoplasmic Sperm Injection (ICSI)
  • Conventional Insemination (IVF)
Record updated
16 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women having IVF with frozen donor sperm at Shady Grove Fertility Center. Their eggs are split between two ways of joining egg and sperm: ICSI and conventional IVF.

Sex
Women only.
Disease stage
Infertility not caused by a male factor. Normal egg supply in the ovaries (AMH > 1 ng/mL, AFC > 10). More than 4 eggs collected at egg retrieval.
Biomarker or test result
AMH > 1 ng/mL and AFC > 10. Donor sperm after washing must have >50% motility and >5mil concentration.

Main reasons for not taking part

  • Donor sperm with significant problems, such as abnormal sperm count, movement or shape
  • Any medical condition that rules out assisted reproduction (ART)

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Any medical condition contraindicating ART
  • Donor Sperm with significant male factor infertility (e.g., abnormal sperm concentration, motility, or morphology)

Where in United States

  • Shady Grove Fertility RockvilleRockville, United StatesContact: Tasha NewsomeTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Intracytoplasmic Sperm Injection (ICSI)Treatment being tested

    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.

  • Conventional Insemination (IVF)Treatment being tested

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prospective Randomized Sibling-Oocyte Trial Comparing Fertilization and Embryo Development Outcomes Between Intracytoplasmic Sperm Injection (ICSI) and Conventional IVF Using Frozen Donor Sperm
Plain-language title
Two ways of fertilizing eggs with frozen donor sperm in female infertilityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
16 September 2025