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

NCT ID: NCT03951194

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

2019-06-13

Study Completion Date

2025-07-30

Brief Summary

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Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.

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 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.

Conditions

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Infertility, Female Perimenopausal Disorder Menstrual Cycle Abnormal

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

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

Group Type EXPERIMENTAL

Autologous Platelet Rich Plasma (PRP) intra ovarian infusion

Intervention Type BIOLOGICAL

Autologous PRP intra ovarian infusion

Participants receiving Platelet Free Plasma (PFP)

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

Group Type PLACEBO_COMPARATOR

Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion

Intervention Type OTHER

Autologous PFP intra ovarian infusion

Interventions

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Autologous Platelet Rich Plasma (PRP) intra ovarian infusion

Autologous PRP intra ovarian infusion

Intervention Type BIOLOGICAL

Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion

Autologous PFP intra ovarian infusion

Intervention Type OTHER

Other Intervention Names

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PRP Platelet Rich Plasma PFP Platelet Free Plasma

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

50 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: STUDY_DIRECTOR

Obstetrician Gynecologist

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

Email: [email protected]

Facility Contacts

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Agni Pantou, MD, PhD Candidate

Role: primary

Konstantinos Pantos, MD,PhD

Role: backup

Other Identifiers

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PRP- Perimenopause

Identifier Type: -

Identifier Source: org_study_id