NCT03951194

Brief Summary

Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 25, 2017

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

June 13, 2019

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

December 24, 2024

Status Verified

January 1, 2024

Enrollment Period

5.6 years

First QC Date

October 25, 2017

Last Update Submit

December 20, 2024

Conditions

Infertility, FemalePerimenopausal DisorderMenstrual Cycle Abnormal

Outcome Measures

Primary Outcomes (2)

  • Restoration of menstrual cycle regularity

    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

    Follow-up period of three months entailing monthly evaluation

Study Arms (2)

Participants receiving PRP treatment

EXPERIMENTAL

Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.

Biological: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion

Participants receiving Platelet Free Plasma (PFP)

PLACEBO COMPARATOR

Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.

Other: Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion

Interventions

Autologous Platelet Rich Plasma (PRP) intra ovarian infusionBIOLOGICAL

Autologous PRP intra ovarian infusion

Also known as: PRP, Platelet Rich Plasma
Participants receiving PRP treatment
Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusionOTHER

Autologous PFP intra ovarian infusion

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

Eligibility Criteria

Age40 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women ≥40 years of age, presenting with cycle irregularities while fulfilling at least one of the respective two criteria: more than seven days difference in menstrual cycle duration between two consecutive cycles OR, presence of a menstrual cycle duration over sixty days and progressive elevation of FSH levels.
  • 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
  • Amenorrhea
  • 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
  • Previous POI diagnosis -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

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Agni Pantou, MD

    Obstetrician Gynecologist

    STUDY DIRECTOR

Central Study Contacts

Mara Simopoulou, PhD

CONTACT

+306979234100marasimopoulou@hotmail.com

Agni Pantou, MD, PhD Candidate

CONTACT

agni.pantou@genesisathens.gr

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

May 15, 2019

Study Start

June 13, 2019

Primary Completion

January 30, 2025

Study Completion

July 30, 2025

Last Updated

December 24, 2024

Record last verified: 2024-01

Locations

GR(1)