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Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders

NCT ID: NCT03937661

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

2019-05-06

Study Completion Date

2025-08-30

Brief Summary

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Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).

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 fresh ET-ICSI cycles' performance in regard to patients presenting with POR. 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 POR patients.

Conditions

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Ovary; Anomaly Infertility, Female

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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Group of participants receiving PRP treatment

Women presenting with POR, treated with autologous PRP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period.

Group Type EXPERIMENTAL

PRP

Intervention Type BIOLOGICAL

Autologous PRP intra ovarian infusion

Control Group: participants receiving Platelet Free Plasma

Women presenting with POR, treated with autologous PFP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Autologous PFP intra ovarian infusion

Interventions

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PRP

Autologous PRP intra ovarian infusion

Intervention Type BIOLOGICAL

Placebo

Autologous PFP intra ovarian infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following)
* Age ≥ 40 years
* AMH \< 1.1 ng/ml OR AFC \< 7
* ≤ 3 oocytes with a conventional stimulation protocol)
* 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
* Cycle irregularities
* 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 -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

35 Years

Maximum Eligible Age

47 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

Phone: +306974447702

Email: [email protected]

Facility Contacts

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Agni Pantou, MD, PhD Candidate

Role: primary

Other Identifiers

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PRP - poor responders

Identifier Type: -

Identifier Source: org_study_id