Status:
UNKNOWN
Ovarian Rejuvenation Using Platelet Rich Plasma (PRP) & Autologous Tissue Stromal Vascular Fraction (tSVF) and Cell Enriched tSVF
Lead Sponsor:
Black Tie Medical, Inc.
Conditions:
Ovarian Failure
Perimenopausal Disorder
Eligibility:
FEMALE
35-60 years
Phase:
PHASE1
Brief Summary
Trial of imaging guided intra-ovarian injection to improve ovarian function in clinical settings of Premature Ovarian Failure, Perimenopausal and /or early postmenopausal symptomatology and related ho...
Detailed Description
Intra-ovarian placement of platelet rich plasma (PRP) has already been demonstrated in several series to return peri-menopausal and early post-menopausal hormone levels towards pre-menopausal levels a...
Eligibility Criteria
Inclusion
- Symptomatology or hormonal derangement for at least 6 months
- Stopped Hormonal Replacement Therapy (HRT) for at least 3 months prior to intervention
- Stopped Botanotherapy / Danazol for 3 months
- Willing to comply with study requirements, including avoiding HRT, Botanotherapy, Danazol for at least 12 months post intervention.
- Women over the age of 35
- Presence of at least one ovary
- Agree to report any pregnancy to the research staff immediately.
- Willing and able to comply with study requirements.
Exclusion
- Current or previous Immune Globulin A (IgA) deficiency
- Current or previous premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality
- Current or previous injuries or adhesions to the pelvis or ovaries
- Current and ongoing pregnancy
- Current and ongoing anticoagulant use
- Known bleeding diathesis
- Current and ongoing major Mental health disorder that precludes participation in the study
- Current and ongoing active substance abuse or dependence
- Prior or current ovarian malignancy, or known genetic mutation
- Current and ongoing chronic pelvic pain other than dyspareunia or vulval/vaginal integument disorders
- History of endometriosis
- Current diagnosis of cancer or active cancer within last 24 months
- Ovarian inaccessibility determined by endovaginal sonography
- Current or previous premature ovarian failure
- Active, untreated Endocrinologic disorders (uncompensated thyroid dysfunction, insulin dependant diabetes (type 1, type2)
- Body Mass Index (BMI) \>30 kg/m2
- Systemic autoimmune disorder
- Know Polycystic Ovarian Syndrome
- Unwilling to terminate ovarian pharmaceuticals or exogenous hormone treatments 3 months prior to entering study, and to avoid exogenous hormones for duration of study
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04444245
Start Date
July 15 2022
End Date
August 15 2025
Last Update
July 19 2022
Active Locations (1)
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1
Fanny Island Campus Medical Building
Colchester, Vermont, United States, 05446