RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-09-15
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07175571

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female patients undergoing IVF with frozen donor sperm at Shady Grove Fertility Center
  2. * Normal ovarian reserve (AMH \> 1 ng/mL, AFC \> 10)
  3. * Absence of male factor infertility
  4. * Post-wash parameters: \>50% motility, \>5mil concentration
  5. * \> 4 oocytes retrieved at time of transvaginal oocyte retrieval
  1. * Donor Sperm with significant male factor infertility (e.g., abnormal sperm concentration, motility, or morphology)
  2. * Any medical condition contraindicating ART

Contacts and Locations

Study Contact

Allison Eubanks, MD
CONTACT
301-400-2432
Allison.Eubanks@sgfertility.com
Tasha Newsome
CONTACT
3015451289
Tasha.Newsome@sgfertility.com

Principal Investigator

Kate Devine, MD
STUDY_CHAIR
Shady Grove Fertility

Study Locations (Sites)

Shady Grove Fertility Rockville
Rockville, Maryland, 20850
United States

Collaborators and Investigators

Sponsor: Shady Grove Fertility Reproductive Science Center

  • Kate Devine, MD, STUDY_CHAIR, Shady Grove Fertility

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-15
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2025-09-15
Study Completion Date2026-05-01

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

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