Platelet Rich Plasma for Ovarian Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ovarian Failure+3 More
Platelet Rich Plasma - Procedure
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This trial is testing whether injecting platelet-rich plasma and stromal vascular fraction into the ovaries can improve ovarian function in women with premature ovarian failure, menopausal symptoms, and/or early postmenopausal symptoms.

Eligible Conditions
  • Ovarian Failure
  • Perimenopausal Disorder
  • Hormone Disturbance

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, 3 months, 6 months, 12 months, 18 months

30 days
Patient Safety For Procedure
Month 18
Bone Density and Body Composition
Month 18
Hormonal Response
Month 18
Ovarian Morphology
Month 12
Health Related Quality of Life
baseline through 18 months
Menstrual Resumption

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

ARM 2 emulsified tSVF and PRP
1 of 4
ARM 3 emulsified tSVF and PRP, enriched with cSVF
1 of 4
ARM 4 Intra-ovarian guided placement
1 of 4
ARM 1 Platelet Rich Plasma
1 of 4

Experimental Treatment

100 Total Participants · 4 Treatment Groups

Primary Treatment: Platelet Rich Plasma · No Placebo Group · Phase 1

ARM 2 emulsified tSVF and PRPExperimental Group · 5 Interventions: lipoaspiration harvest tSVF, Platelet Rich Plasma, emulsification tSVF, Endovaginal Ultrasound, Normal Saline (NS) .9% 10 mL Injection · Intervention Types: Procedure, Procedure, Device, Procedure, Drug
ARM 3 emulsified tSVF and PRP, enriched with cSVFExperimental Group · 6 Interventions: lipoaspiration harvest tSVF, Platelet Rich Plasma, emulsification tSVF, Endovaginal Ultrasound, Normal Saline (NS) .9% 10 mL Injection, Cellular Isolation cSVF · Intervention Types: Procedure, Procedure, Device, Procedure, Drug, Device
ARM 4 Intra-ovarian guided placement
Procedure
Experimental Group · 1 Intervention: Endovaginal Ultrasound · Intervention Types: Procedure
ARM 1 Platelet Rich PlasmaExperimental Group · 3 Interventions: lipoaspiration harvest tSVF, Platelet Rich Plasma, Endovaginal Ultrasound · Intervention Types: Procedure, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platelet Rich Plasma
2016
Completed Phase 4
~1000

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months, 6 months, 12 months, 18 months

Who is running the clinical trial?

Black Tie Medical, Inc.Lead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
I am willing to comply with the study requirements, including avoiding HRT, Botanotherapy, and Danazol for at least 12 months post intervention.
is necessary for the development of female reproductive system
Did not take antibiotics during the 3 months prior to the study Had regular menstrual periods in the past 3 months Had a follicle-stimulating hormone (FSH) level of less than 20 IU/L The study participants had to: Stop taking hormonal replacement therapy for at least three months before the intervention
Symptoms that have been going on for at 6 months or more and that are likely due to a hormonal imbalance.
I was taking Danazol for about 3 months and then I stopped taking it because it wasn't really helping.
You are a woman over the age of 35.
If you are pregnant, please let the research staff know immediately.
Compliant with study requirements.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: November 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
California50.0%
Vermont50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Fanny Island Campus Medical Building100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References