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Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients (PRP)

Primary Purpose

Menopause, Premature, Menopause Related Conditions, Menopausal Syndrome

Status

Recruiting

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Autologous Platelet Rich Plasma

Placebo-Platelet Free Plasma

About this trial

This is an interventional treatment trial for Menopause, Premature

Eligibility Criteria

25 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Genesis ACRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Participants receiving PRP treatment

Participants receiving Platelet Free Plasma (PFP) treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Restoration of menstrual cycle

Regular menstrual cycle

Serum FSH levels

Serum FSH levels evaluated monthly for three consecutive months

Secondary Outcome Measures

Serum AMH levels

Serum ΑΜΗ levels evaluated monthly for three consecutive months

Serum LH levels

Serum LH levels evaluated monthly for three consecutive months

Serum Estradiol levels

Serum estradiol levels evaluated monthly for three consecutive months

Serum Progesteron levels

Serum progesterone levels evaluated monthly for three consecutive months

Antral Follicle Count (AFC)

AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months

Full Information

NCT ID

NCT04031456

First Posted

October 25, 2017

Last Updated

February 22, 2023

Sponsor

Genesis Athens Clinic

Collaborators

National and Kapodistrian University of Athens

1. Study Identification

Unique Protocol Identification Number

NCT04031456

Brief Title

Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients

Acronym

PRP

Official Title

Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 30, 2019 (Actual)

Primary Completion Date

January 30, 2026 (Anticipated)

Study Completion Date

July 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genesis Athens Clinic

Collaborators

National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on reactivating ovarian functionality and on promoting folliculogenesis in regard to patients presenting with POI. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on restoring ovarian tissue functionality in POI patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menopause, Premature, Menopause Related Conditions, Menopausal Syndrome, Premature Ovarian Failure, Ovarian Failure, Premature

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Participants receiving PRP treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Participants receiving Platelet Free Plasma (PFP) treatment

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Autologous Platelet Rich Plasma

Other Intervention Name(s)

PRP, Platelet Rich Plasma

Intervention Description

Autologous PRP intra ovarian infusion

Intervention Type

Biological

Intervention Name(s)

Placebo-Platelet Free Plasma

Other Intervention Name(s)

PFP

Intervention Description

Autologous PFP intra ovarian infusion

Primary Outcome Measure Information:

Title

Restoration of menstrual cycle

Description

Regular menstrual cycle

Time Frame

Three months

Title

Serum FSH levels

Description

Serum FSH levels evaluated monthly for three consecutive months

Time Frame

Follow-up period of three months entailing monthly evaluation

Secondary Outcome Measure Information:

Title

Serum AMH levels

Description

Serum ΑΜΗ levels evaluated monthly for three consecutive months

Time Frame

Follow-up period of three months entailing monthly evaluation

Title

Serum LH levels

Description

Serum LH levels evaluated monthly for three consecutive months

Time Frame

Follow-up period of three months entailing monthly evaluation

Title

Serum Estradiol levels

Description

Serum estradiol levels evaluated monthly for three consecutive months

Time Frame

Follow-up period of three months entailing monthly evaluation

Title

Serum Progesteron levels

Description

Serum progesterone levels evaluated monthly for three consecutive months

Time Frame

Follow-up period of three months entailing monthly evaluation

Title

Antral Follicle Count (AFC)

Description

AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months

Time Frame

Follow-up period of three months entailing monthly evaluation

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mara Simopoulou, PhD

Phone

+306979234100

marasimopoulou@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Agni Pantou, MD, PhD Candidate

Facility Information:

Facility Name

Genesis AC

City

Athens

ZIP/Postal Code

15232

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mara Simopoulou, PhD

First Name & Middle Initial & Last Name & Degree

Agni Pantou, MD

First Name & Middle Initial & Last Name & Degree

Konstantinos Pantos, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients

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