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

NCT07175571 | Recruiting

• 1 other identifier: SISTER Study
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Blastulation Rate

  The blastulation rate is defined as the number of "usable" blastocysts divided by the number of oocytes inseminated in each arm (ICSI and conventional IVF). A blastocyst is considered "usable" if it meets laboratory criteria for either cryopreservation or embryo transfer. Assessment is performed on Days 5-7 after fertilization using standard morphological grading under light microscopy.

  Day 5 to Day 7 post-insemination

Secondary Outcomes (4)

• Fertilization Rate

  Approximately 16-18 hours post-insemination

• Total Fertilization Failure (TFF)

  Approximately 16-18 hours post-insemination

• Proportion of High-Quality Blastocysts

  Day 5 to Day 7 post-insemination

• Early Clinical Pregnancy Rate

  Approximately 5 to 7 weeks after embryo transfer

Study Arms (2)

Intracytoplasmic Sperm Injection (ICSI)

EXPERIMENTAL

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.

Procedure: Intracytoplasmic Sperm Injection (ICSI)

Conventional Insemination (IVF)

EXPERIMENTAL

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.

Procedure: Conventional Insemination (IVF)

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.

Intracytoplasmic Sperm Injection (ICSI)

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.

Conventional Insemination (IVF)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shady Grove Fertility Reproductive Science Center: lead

Study Sites (1)

Shady Grove Fertility Rockville

Rockville, Maryland, 20850, United States

RECRUITING

Related Publications (7)

• Romero-Galisteo RP, Pinero-Pinto E, Palomo-Carrion R, Luque-Moreno C, Molina-Torres G, Gonzalez-Sanchez M. Translation, cross-cultural adaptation and validation of the Rett syndrome motor evaluation scale (RESMES): Spanish version. Eur J Paediatr Neurol. 2023 Nov;47:72-79. doi: 10.1016/j.ejpn.2023.09.008. Epub 2023 Sep 28.

  PMID: 37788534 BACKGROUND

• Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.

  PMID: 1351601 BACKGROUND

• Hao G, Zhou X, Yan H, Wang X, Qiao L, Ni D, Shu W, Yu T. Emotional experience elicited by direct electrical stimulation: Case series and literature review. Epilepsia Open. 2023 Jun;8(2):547-558. doi: 10.1002/epi4.12729. Epub 2023 Apr 4.

  PMID: 36932033 BACKGROUND

• Mao Z, Yao H, Zou Q, Zhang W, Dong Y. Digital Contact Tracing Based on a Graph Database Algorithm for Emergency Management During the COVID-19 Epidemic: Case Study. JMIR Mhealth Uhealth. 2021 Jan 22;9(1):e26836. doi: 10.2196/26836.

  PMID: 33460389 BACKGROUND

• Teodorescu M, Barnet JH, Hagen EW, Palta M, Young TB, Peppard PE. Association between asthma and risk of developing obstructive sleep apnea. JAMA. 2015 Jan 13;313(2):156-64. doi: 10.1001/jama.2014.17822.

  PMID: 25585327 BACKGROUND

• Mo DY, Tang YM, Wu EY, Tang V. Theoretical model of investigating determinants for a successful Electronic Assessment System (EAS) in higher education. Educ Inf Technol (Dordr). 2022;27(9):12543-12566. doi: 10.1007/s10639-022-11098-1. Epub 2022 Jun 3.

  PMID: 35676938 BACKGROUND

• Zhang R, Xu S, Yuan M, Guo L, Xie L, Liao Y, Xu Y, Fu X. An ultrasmall PVP-Fe-Cu-Ni-S nano-agent for synergistic cancer therapy through triggering ferroptosis and autophagy. Nanoscale. 2023 Aug 3;15(30):12598-12611. doi: 10.1039/d3nr02708b.

  PMID: 37462439 BACKGROUND

MeSH Terms

Conditions

Infertility, Female; Helping Behavior

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Kate Devine, MD

  Shady Grove Fertility

  STUDY CHAIR

Central Study Contacts

Allison Eubanks, MD

CONTACT

301-400-2432; Allison.Eubanks@sgfertility.com

Tasha Newsome

CONTACT

3015451289; Tasha.Newsome@sgfertility.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director and Chief Research Officer

Model Details: This is a randomized sibling-oocyte controlled trial in which each participant's retrieved oocytes are split between two insemination methods: intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF). Randomization occurs at the oocyte level, not at the participant level. For participants with an even number of mature oocytes, half are randomly assigned to ICSI and half to conventional IVF. For participants with an odd number, the extra oocyte is randomly allocated using a pre-specified scheme. This within-subject design allows direct comparison of fertilization and embryo development outcomes between the two methods while minimizing inter-patient variability.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: September 15, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)