Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders (PRP)

Genesis Athens Clinic

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Ovary; Anomaly; Infertility, Female

Treatments: Biological: Placebo; Biological: PRP

Study type: Interventional

Funder types: Other

Identifiers

NCT03937661

PRP - poor responders

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 35 to 47 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Group of participants receiving PRP treatment

Experimental group

Description:

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.

Treatment:

Biological: PRP

Control Group: participants receiving Platelet Free Plasma

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo