Inovium Ovarian Rejuvenation Trials

Completed · Phase 1

Conditions studied: Perimenopausal Disorder, Menopause, Menopause, Premature, Menopause Related Conditions, Menopause Premature Symptomatic, Menopause Premature Asymptomatic, Premature Ovarian Failure, Premature Ovarian Failure, Familial, Premature Ovarian Failure 2A, Premature Ovarian Failure 3, Premature Ovarian Failure 4, Premature Ovarian Failure 1, Premature Ovarian Failure 5, Premature Ovarian Failure 6, Premature Ovarian Failure 7, Premature Ovarian Failure 9, Premature Ovarian Failure 8, Infertility, Infertility, Female, Infertility Unexplained

In brief

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.

Key facts

Study ID

NCT03178695

Run by

Ascendance Biomedical

People needed

200

Starts

2017-06-01

Expected to finish

2018-05-01

Last updated by the study team

2020-04-20

Who can join

Age: 35 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Center for Advanced Genetics — Carlsbad, California, United States

Full record on ClinicalTrials.gov

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