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

NCT ID: NCT03916978

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-21

Study Completion Date

2026-07-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Infertility, Female Anovulatory Infertility Menopause Amenorrhea

Keywords

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Ovarian rejuvenation Ovarian reactivation; ovulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Participants receiving PRP treatment

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

Group Type EXPERIMENTAL

Autologous PRP intra ovarian infusion

Intervention Type BIOLOGICAL

Autologous PRP intra ovarian infusion

Control Group: Participants receiving Platelet Free Plasma

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

Group Type PLACEBO_COMPARATOR

Autologous PFP intra ovarian infusion

Intervention Type BIOLOGICAL

Autologous PFP intra ovarian infusion

Interventions

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Autologous PRP intra ovarian infusion

Autologous PRP intra ovarian infusion

Intervention Type BIOLOGICAL

Autologous PFP intra ovarian infusion

Autologous PFP intra ovarian infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role collaborator

Genesis Athens Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agni Pantou, MD

Role: PRINCIPAL_INVESTIGATOR

Centre of Human Reproduction, Genesis Athens Clinic

Locations

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Genesis AC

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Mara Simopoulou, PhD

Role: CONTACT

Phone: +306979234100

Email: [email protected]

Agni Pantou, MD

Role: CONTACT

Phone: +306974447702

Email: [email protected]

Facility Contacts

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Agni Pantou, MD

Role: primary

Other Identifiers

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PRP - Menopausal women

Identifier Type: -

Identifier Source: org_study_id