Hormone Disturbance Clinical Trial
— OVAR-REJUVOfficial title:
Re-establishment of Ovarian Hormonal Function, Delay of Menopause, or Reversal of Early Menopause With High Density (HD PRP), tSVF + PRP, or Cell Enriched tSVF + PRP by Ultrasound Guided Ovarian Injection
Verified date | July 2022 |
Source | Black Tie Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 hormonal deficiencies. The study will compare the effectiveness of autologous Platelet Rich Plasma alone versus Stromal Vascular Fraction (tSVF and/or cellular stromal vascular fraction (cSVF) in combination with Platelet Rich Plasma as regards efficacy and duration of ovarian reactivation in women with acquired Premature Ovarian Failure, Menopausal, and Perimenopausal women.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | August 15, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years to 60 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Fanny Island Campus Medical Building | Colchester | Vermont |
Lead Sponsor | Collaborator |
---|---|
Black Tie Medical, Inc. |
United States,
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* Note: There are 64 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health Related Quality of Life | Utian Menopausal Quality of Life (UQoL )Instrument and the SF-36v2 physical and mental health quality of life surveys. These are norm based clinically validated and widely accepted measurement tools. Improving scores would indicate increased subject satisfaction with general physical and mental health for the SF-36v2 survey, and reduced menopausal-specific symptomatology for the Utian Menopausal Quality of Life survey. | Baseline, 6 months, 12 months | |
Primary | Patient Safety For Procedure | Reporting of all Adverse Events, Severe Adverse Events | 30 days | |
Secondary | Menstrual Resumption | Journal documentation by subjects of menstrual frequency, duration | baseline through 18 months | |
Secondary | Hormonal Response | Concentrations of Follicular Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol, Anti-Mullerian Hormone. Percentage of patients with significant reductions in FSH and LH, increases in Estradiol and Anti-Mullerian Hormone will be tabulated. Changes in these directions will indicate improved hormonal status that has been shown to correlate with improved health status across a wide range of measures. | Baseline, 3 months, 6 months, 12 months, 18 months | |
Secondary | Ovarian Morphology | Endovaginal Sonography for Ovarian Volume | Baseline, 6 month, 12 month, 18 month | |
Secondary | Bone Density and Body Composition | Evaluation of Bone density and Body Composition (fat /muscle proportions) by Single Photon Absorptiometry | Baseline, 12 and/or 18 months |
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