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Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women (PRP)

Primary Purpose

Infertility, Female, Perimenopausal Disorder, Menstrual Cycle Abnormal

Status
Recruiting
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Autologous Platelet Rich Plasma (PRP) intra ovarian infusion
Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion
Sponsored by
Genesis Athens Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

40 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Restoration of menstrual cycle regularity
Regular Menstrual cycle
Serum FSH levels
Serum FSH levels evaluated monthly for three consecutive months.

Secondary Outcome Measures

Serum AMH levels
Serum AMH levels evaluated monthly for three consecutive months.
Serum LH levels
Serum LH levels evaluated monthly for three consecutive months.
Serum Estradiol levels
Serum etsradiol levels evaluated monthly for three consecutive months.
Serum Progesteron levels
Serum progesterone levels evaluated monthly for three consecutive months.
Antral Follicle Count
AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months.

Full Information

First Posted
October 25, 2017
Last Updated
February 22, 2023
Sponsor
Genesis Athens Clinic
Collaborators
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT03951194
Brief Title
Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women
Acronym
PRP
Official Title
Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Perimenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
July 30, 2025 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.
Detailed Description
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and hormonal profile of perimenopausal women. 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 improving ovarian tissue functionality in perimenopausal women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Perimenopausal Disorder, Menstrual Cycle Abnormal

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
Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.
Arm Title
Participants receiving Platelet Free Plasma (PFP)
Arm Type
Placebo Comparator
Arm Description
Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.
Intervention Type
Biological
Intervention Name(s)
Autologous Platelet Rich Plasma (PRP) intra ovarian infusion
Other Intervention Name(s)
PRP, Platelet Rich Plasma
Intervention Description
Autologous PRP intra ovarian infusion
Intervention Type
Other
Intervention Name(s)
Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion
Other Intervention Name(s)
PFP, Platelet Free Plasma
Intervention Description
Autologous PFP intra ovarian infusion
Primary Outcome Measure Information:
Title
Restoration of menstrual cycle regularity
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 AMH 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 etsradiol 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
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
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mara Simopoulou, PhD
Phone
+306979234100
Email
marasimopoulou@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Agni Pantou, MD, PhD Candidate
Email
agni.pantou@genesisathens.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agni Pantou, MD
Organizational Affiliation
Obstetrician Gynecologist
Official's Role
Study Director
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
Agni Pantou, MD, PhD Candidate
Email
agni.pantou@genesisathens.gr
First Name & Middle Initial & Last Name & Degree
Konstantinos Pantos, MD,PhD

12. IPD Sharing Statement

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Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women

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