The ROAR Study: Reactive Oxygen Species and Reproduction | NCT06831019

Studies
The ROAR Study: Reactive Oxygen Species and Reproduction

NCT06831019

Sponsor

University of California, San Francisco

Status

Recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

1,100Estimated

Phase

Not provided

Conditions

Ovarian Aging
IVF Outcome
Oxidative Stress

Interventions

Oxidative stress markers

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2025Actual

Primary Completion Date

Mar 1, 2027Estimated

Completion Date

Mar 1, 2027Estimated

First Submitted Date

Feb 13, 2025

First Submission Date that Met QC Criteria

Feb 13, 2025

First Posted Date

Feb 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2026

Last Update Posted Date

Feb 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Couples undergoing IVF		Heterosexual couples undergoing IVF	Diagnostic Test: Oxidative stress markers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Male and Female couples

Minimum Age

18 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

Heterosexual couples undergoing fresh IVF cycle

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elena Hoskin, BS	Contact	(415) 885-3598		elena.hoskin@ucsf.edu

Overall Officials

Name	Affiliation	Role
Mitchell Rosen, MD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco	Recruiting	San Francisco	California	94158	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided