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

Phase 3RecruitingNCT03937661

Genesis Athens Clinic100 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Ovary; Anomaly Infertility, Female

Interventions

PRPBIOLOGICAL

Autologous PRP intra ovarian infusion

PlaceboBIOLOGICAL

Autologous PFP intra ovarian infusion

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 47 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Genesis AC

Athens, Greece

RECRUITING

Outcomes

Primary Outcomes

Number of oocytes retrieved

Number of oocytes retrieved following COS in the first fresh ICSI-ET cycle following intervation performed on the third month of the follow-up period

Time frame: 34-36 hours following hCG administration

AMH levels

Serum AMH levels evaluated monthly for three consecutive months

Time frame: Follow-up period of three months entailing monthly evaluation

Secondary Outcomes

Clinical pregnancy rate

Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the third month of the follow-up period

Time frame: 6-7 weeks following last menstruation

Antral Follicle Count

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

Central Contacts

Mara Simopoulou, PhD

CONTACT

+306979234100 marasimopoulou@hotmail.com

Agni Pantou, MD, PhD Candidate

CONTACT

+306974447702 agni.pantou@genesisathens.gr

Data from ClinicalTrials.gov

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