CompletedPhase 1

Inovium Ovarian Rejuvenation Trials

United States200 participantsStarted 2017-06-01

Plain-language summary

The Inovium Ovarian Rejuvenation Treatment is a PRP-based autologous treatment used in combination with a stimulated IVF sequence and Pre-Implantation Genetic Screening to treat infertility in women experiencing menopause, perimenopause, and premature ovarian failure.

Who can participate

Age range

35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed and dated informed consent * Women over the age of 35 * Primary or secondary amenorrhea at least for 3-6 months * Presence of at least one ovary * Agree to report any pregnancy to the research staff immediately. * Willing and able to comply with study requirements. * Willing to receive IVF to get pregnant as part of the experimental protocol. Exclusion Criteria: * Men will be excluded from the study. * Current or previous IgA deficiency * Current or previous premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality * Current or previous great injuries or adhesions to the pelvis or ovaries * Current and ongoing pregnancy * Current and ongoing anticoagulant use for which plasma infusion appears contraindicated * Current and ongoing major Mental health disorder that precludes participation in the study * Current and ongoing active substance abuse or dependence * Current and ongoing gynecological or non-gynecological cancer * Current and ongoing chronic pelvic pain

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Positive IVF

Timeframe: 12 months

Positive Pregnancy and Conception

Timeframe: 12 months

Trial details

NCT IDNCT03178695

SponsorAscendance Biomedical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-01

View on ClinicalTrials.gov More Perimenopausal Disorder trials