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

NCT ID: NCT04031456

Last Updated: 2024-12-24

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

2019-07-30

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 patients' hormonal profile in patients presenting with POI.

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 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.

Conditions

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

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

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

Group Type EXPERIMENTAL

Autologous Platelet Rich Plasma

Intervention Type BIOLOGICAL

Autologous PRP intra ovarian infusion

Participants receiving Platelet Free Plasma (PFP) treatment

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

Group Type PLACEBO_COMPARATOR

Placebo-Platelet Free Plasma

Intervention Type BIOLOGICAL

Autologous PFP intra ovarian infusion

Interventions

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Autologous Platelet Rich Plasma

Autologous PRP intra ovarian infusion

Intervention Type BIOLOGICAL

Placebo-Platelet Free Plasma

Autologous PFP intra ovarian infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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PRP Platelet Rich Plasma PFP

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

39 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

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, PhD Candidate

Role: CONTACT

Facility Contacts

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Mara Simopoulou, PhD

Role: primary

Other Identifiers

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PRP- POI

Identifier Type: -

Identifier Source: org_study_id