Ovarian AgingROARNCT06831019
The ROAR Study: Reactive Oxygen Species and Reproduction
An observational study of Ovarian Aging and IVF Outcome, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 yearsHealthy volunteers can take part
- Conditions the study is for
- Ovarian Aging, IVF Outcome, Oxidative Stress
- What is being tested?
- Oxidative stress markers
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Heterosexual couples undergoing fresh IVF cycle
Who may be able to join
- 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
Who cannot join
- Female partner age 44 or older
- Planning fresh transfer (hybrid PGS cycle)
- Cleavage stage biopsy
- Planning to use frozen sperm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
About this study
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
- Being tested
- Oxidative stress markers
- Keywords
- oxidative stress, ovarian aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxidative stress markersDiagnostic test
We will measure markers of oxidative stress in the follicular fluid, semen, and blood and correlate this with IVF and reproductive outcomes
| Study group | Role | What they receive |
|---|---|---|
| Couples undergoing IVF | Heterosexual couples undergoing IVF Receives: Diagnostic Test: Oxidative stress markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Implantation rate of euploid embryos that result from a specific oxidative stress environment
Measured: From enrollment to transfer of all embryos - can be anywhere from 8 weeks to 1 year (or sometimes longer if pregnancy is achieved)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start7 Jul 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian AgingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Rosen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831019
- Sponsor's protocol ID
- 24-42357
- Acronym
- ROAR
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ROAR Study: Reactive Oxygen Species and Reproduction
- ClinicalTrials.gov ID
- NCT06831019
- Acronym / sponsor ID
- ROAR / 24-42357
- Conditions
- Ovarian Aging, IVF Outcome, Oxidative Stress
- Keywords
- oxidative stress, ovarian aging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Couples undergoing IVF | – | Diagnostic Test: Oxidative stress markersHeterosexual couples undergoing IVF |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Heterosexual couples undergoing fresh IVF cycle
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Female partner age 44 or older
- Planning fresh transfer (hybrid PGS cycle)
- Cleavage stage biopsy
- Planning to use frozen sperm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxidative stress markersWe will measure markers of oxidative stress in the follicular fluid, semen, and blood and correlate this with IVF and reproductive outcomes | Diagnostic test | Couples undergoing IVF |
Primary outcome
Implantation rate
Time frame: From enrollment to transfer of all embryos - can be anywhere from 8 weeks to 1 year (or sometimes longer if pregnancy is achieved)
Implantation rate of euploid embryos that result from a specific oxidative stress environment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Ovarian Aging
Enrolling by invitationObservational study
The Longitudinal Evaluation of Ovarian Aging and Cardiovascular Risk
Infertility, Cardiovascular Risk Factor
Not yet recruitingObservational study
The Bone and hEArt Health Consequences of Ovarian agiNg (BEACON) Study
Ovarian Aging, Adverse Pregnancy Outcomes
Active, not recruiting
Ovarian Function Following Intraovarian Injection of PRP
Diminished Ovarian Reserve, Diminished Ovarian Reserve Due to Advanced Maternal Age
Active, not recruitingPhase 2
Effect of Rapamycin in Ovarian Aging
Perimenopausal
RecruitingObservational study
Follicular Fluid microRNAs in Ovarian Aging and Reproduction
Ovarian Aging, In Vitro Fertilisation (IVF) Treatment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mitchell Rosen, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Aging and IVF Outcome, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Hoskin, BS ((415) 885-3598, elena.hoskin@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate (time frame: From enrollment to transfer of all embryos - can be anywhere from 8 weeks to 1 year (or sometimes longer if pregnancy is achieved)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.