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Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women (PRP)

Primary Purpose

Infertility, Female, Anovulatory Infertility, Menopause

Status
Recruiting
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Autologous PRP intra ovarian infusion
Autologous 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 focused on measuring Ovarian rejuvenation, Ovarian reactivation; ovulation

Eligibility Criteria

45 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Genesis ACRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Participants receiving PRP treatment

Control Group: Participants receiving Platelet Free Plasma

Arm Description

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

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

Outcomes

Primary Outcome Measures

Restoration of menstrual cycle
Menstrual cycle restoration
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 estradiol levels
Serum estradiol levels evaluated monthly for three consecutive months.
Serum LH levels
Serum LH levels evaluated monthly for three consecutive months.
Serum progesterone 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
September 24, 2023
Sponsor
Genesis Athens Clinic
Collaborators
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT03916978
Brief Title
Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women
Acronym
PRP
Official Title
Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 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
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 restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.
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 menopausal 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 restoring ovarian tissue functionality in menopausal women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Anovulatory Infertility, Menopause, Amenorrhea
Keywords
Ovarian rejuvenation, Ovarian reactivation; ovulation

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
Menopausal women minimum 45 years of age, receiving ovarian PRP treatment.
Arm Title
Control Group: Participants receiving Platelet Free Plasma
Arm Type
Placebo Comparator
Arm Description
Women in menopause, 45-55 years old, treated with autologous PFP intra ovarian infusion.
Intervention Type
Biological
Intervention Name(s)
Autologous PRP intra ovarian infusion
Intervention Description
Autologous PRP intra ovarian infusion
Intervention Type
Biological
Intervention Name(s)
Autologous PFP intra ovarian infusion
Intervention Description
Autologous PFP intra ovarian infusion
Primary Outcome Measure Information:
Title
Restoration of menstrual cycle
Description
Menstrual cycle restoration
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 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 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 progesterone 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
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
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
Phone
+306974447702
Email
agni.pantou@genesisathens.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agni Pantou, MD
Organizational Affiliation
Centre of Human Reproduction, Genesis Athens Clinic
Official's Role
Principal Investigator
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
Email
agni.pantou@genesisathens.gr
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

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Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women

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