The ROAR Study: Reactive Oxygen Species and Reproduction

NCT06831019 | Recruiting

• 1 other identifier: 24-42357
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study characterizing follicular fluid and serum levels of oxidative stress in women with various infertility diagnoses undergoing in vitro fertilization, and assessing the relationship of oxidative stress to oocyte competence as determined by embryo development outcomes. Furthermore, we will measure oxidative stress in sperm and correlate the overall oxidative stress within the couple with IVF and pregnancy outcomes of the resultant embryos.

Conditions

Ovarian Aging; IVF Outcome; Oxidative Stress

Keywords

oxidative stress; ovarian aging

Outcome Measures

Primary Outcomes (1)

• Implantation rate

  Implantation rate of euploid embryos that result from a specific oxidative stress environment

  From enrollment to transfer of all embryos - can be anywhere from 8 weeks to 1 year (or sometimes longer if pregnancy is achieved)

Study Arms (1)

Couples undergoing IVF

Heterosexual couples undergoing IVF

Diagnostic Test: Oxidative stress markers

Interventions

Oxidative stress markers DIAGNOSTIC_TEST

We will measure markers of oxidative stress in the follicular fluid, semen, and blood and correlate this with IVF and reproductive outcomes

Couples undergoing IVF

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: Male and Female couples
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Heterosexual couples undergoing fresh IVF cycle

You may qualify if:

• Female age 18-43 years
• Subjects planning blastocyst culture for preimplantation genetic screening (PGS) for aneuploidy.
• Male partners 18 years of age or older.
• Must be a registered patient at UCSF Center for Reproductive Health
• Patient and partner must both be physically present on the day of retreival

You may not qualify if:

• Female partner age 44 or older
• Planning fresh transfer (hybrid PGS cycle)
• Cleavage stage biopsy
• Planning to use frozen sperm

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Follicular fluid, seminal plasma, blood - serum and plasma

Study Officials

• Mitchell Rosen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Hoskin, BS

CONTACT

(415) 885-3598; elena.hoskin@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 17, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)