NCT03916978

Brief Summary

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.

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 May 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%
May 2019Jul 2026

First Submitted

Initial submission to the registry

October 25, 2017

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 21, 2019

Completed
6.7 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 27, 2024

Status Verified

December 1, 2024

Enrollment Period

6.7 years

First QC Date

October 25, 2017

Last Update Submit

December 20, 2024

Conditions

Infertility, FemaleAnovulatory InfertilityMenopauseAmenorrhea

Keywords

Ovarian rejuvenationOvarian reactivation; ovulation

Outcome Measures

Primary Outcomes (2)

  • Restoration of menstrual cycle

    Menstrual cycle restoration

    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 estradiol levels

    Follow-up period of three months entailing monthly evaluation

  • Serum LH levels

    Follow-up period of three months entailing monthly evaluation

  • Serum progesterone 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

Menopausal women minimum 45 years of age, receiving ovarian PRP treatment.

Biological: Autologous PRP intra ovarian infusion

Control Group: Participants receiving Platelet Free Plasma

PLACEBO COMPARATOR

Women in menopause, 45-55 years old, treated with autologous PFP intra ovarian infusion.

Biological: Autologous PFP intra ovarian infusion

Interventions

Autologous PRP intra ovarian infusionBIOLOGICAL

Autologous PRP intra ovarian infusion

Participants receiving PRP treatment
Autologous PFP intra ovarian infusionBIOLOGICAL

Autologous PFP intra ovarian infusion

Control Group: Participants receiving Platelet Free Plasma

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 45-55 years old
  • Amenorrhea for at least 12 months
  • 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
  • Previous POI diagnosis
  • Abnormal karyotype
  • Endometriosis
  • Adenomyosis
  • Fibroids and adhesions
  • Infections in reproductive system
  • Current or previous diagnosis of reproductive system cancer
  • 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

Infertility, FemaleAmenorrhea

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Agni Pantou, MD

    Centre of Human Reproduction, Genesis Athens Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mara Simopoulou, PhD

CONTACT

+306979234100marasimopoulou@hotmail.com

Agni Pantou, MD

CONTACT

+306974447702agni.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

April 16, 2019

Study Start

May 21, 2019

Primary Completion

January 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations

GR(1)