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Inovium Ovarian Rejuvenation Trials

NCT03178695 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-04-20

No results posted yet for this study

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.

Conditions

  • 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

Interventions

OTHER

Autologous PRP injection into human ovarian tissue

Using FDA-approved equipment, blood plasma is received from participant, isolated/enriched into PRP, and infused into the ovaries under transvaginal ultrasound guidance.

Sponsors & Collaborators

  • Ascendance Biomedical

    lead INDUSTRY

Principal Investigators

  • E Scott Sills, MD PhD · Center for Advanced Genetics (CAG)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2018-05-01
Completion
2018-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03178695 on ClinicalTrials.gov