NCT04031456

Brief Summary

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
3mo left

Started Jul 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jul 2019Jul 2026

First Submitted

Initial submission to the registry

October 25, 2017

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

July 30, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

6.5 years

First QC Date

October 25, 2017

Last Update Submit

December 20, 2024

Conditions

Menopause, PrematureMenopause Related ConditionsMenopausal SyndromePremature Ovarian FailureOvarian Failure, Premature

Outcome Measures

Primary Outcomes (2)

  • Restoration of menstrual cycle

    Regular menstrual cycle

    Three months

  • Serum FSH levels

    Serum FSH levels evaluated monthly for three consecutive months

    Follow-up period of three months entailing monthly evaluation

Secondary Outcomes (5)

  • Serum AMH levels

    Follow-up period of three months entailing monthly evaluation

  • Serum LH levels

    Follow-up period of three months entailing monthly evaluation

  • Serum Estradiol levels

    Follow-up period of three months entailing monthly evaluation

  • Serum Progesteron levels

    Follow-up period of three months entailing monthly evaluation

  • Antral Follicle Count (AFC)

    Follow-up period of three months entailing monthly evaluation

Study Arms (2)

Participants receiving PRP treatment

EXPERIMENTAL

Women presenting with POI, 25-39 years of age, treated with autologous PRP intra ovarian infusion

Biological: Autologous Platelet Rich Plasma

Participants receiving Platelet Free Plasma (PFP) treatment

PLACEBO COMPARATOR

Women presenting with POI, 25-39 years of age, treated with autologous PFP intra ovarian infusion

Biological: Placebo-Platelet Free Plasma

Interventions

Autologous Platelet Rich PlasmaBIOLOGICAL

Autologous PRP intra ovarian infusion

Also known as: PRP, Platelet Rich Plasma
Participants receiving PRP treatment
Placebo-Platelet Free PlasmaBIOLOGICAL

Autologous PFP intra ovarian infusion

Also known as: PFP
Participants receiving Platelet Free Plasma (PFP) treatment

Eligibility Criteria

Age25 Years - 39 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \< 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels \>25 IU/L recorded on two occasions \>4 weeks apart
  • Normal Karyotype: 46, XX
  • Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.
  • Willing to comply with study requirements

You may not qualify if:

  • Any pathological disorder related to reproductive system anatomy
  • AMH \> 8 pmol/L
  • Endometriosis
  • Adenomyosis
  • Fibroids and adhesions
  • Infections in reproductive system
  • Current or previous diagnosis of cancer in reproductive system
  • History of familiar cancer in reproductive system
  • Severe male factor infertility
  • Prior referral for PGT
  • Ovarian inaccessibility
  • Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
  • BMI\>30 kg/m2 or BMI\<18.5 kg/m2
  • Systematic autoimmune disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genesis AC

Athens, 15232, Greece

RECRUITING

MeSH Terms

Conditions

Menopause, PrematurePrimary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Central Study Contacts

Mara Simopoulou, PhD

CONTACT

+306979234100marasimopoulou@hotmail.com

Agni Pantou, MD, PhD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

July 24, 2019

Study Start

July 30, 2019

Primary Completion

January 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

December 24, 2024

Record last verified: 2024-12

Locations

GR(1)