Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

NCT05181748 | Recruiting Phase 2

• 1 other identifier: GenesisAC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Autologous platelet rich plasma (PRP) intraovarian infusion may improve ovarian response to controlled ovarian stimulation as well as the hormonal profile of poor ovarian response infertile women subjected to intracytoplasmic sperm injection (ICSI) treatment.

Conditions

Poor Response to Ovulation Induction; Infertility, Female; Ovarian Insufficiency; Ovarian Failure; Reproductive Sterility; Ovary; Anomaly

Keywords

Autologous platelet rich plasma intraovarian infusion; Assisted reproduction; PRP; In vitro fertilization; Ovarian functionality improvement

Outcome Measures

Primary Outcomes (2)

• Number of oocytes retrieved

  Number of oocytes retrieved following controlled ovarian stimulation in the first fresh ICSI-ET cycle performed on the first menstrual cycle following intervention

  34-36 hours following ovulation triggering

• Anti-Müllerian Hormone Levels (AMH)

  Serum anti-müllerian hormone (AMH) levels evaluated in the first menstrual cycle following intervention

  On day 2-3 of the first menstrual cycle post intervention

Secondary Outcomes (2)

• Clinical pregnancy rate

  6-7 weeks following last menstruation

• Antral Follicle Count (AFC)

  On day 2-3 of the first menstrual cycle post intervention

Study Arms (2)

Experimental: Group of participants receiving PRP treatment

EXPERIMENTAL

Women presenting with POR, treated with autologous PRP intraovarian infusion during the mid-luteal phase, undergoing a subsequent stimulated fresh ET-ICSI cycle on the first month following PRP infusion

Biological: Autologous platelet rich plasma

Control Group: Group of participants receiving standard protocol

NO INTERVENTION

Women presenting with POR undergoing a stimulated fresh ET-ICSI cycle

Interventions

Autologous platelet rich plasma BIOLOGICAL

Preparation of PRP will be performed immediately following blood sample collection. Blood samples will be collected from the median antebrachial vein. PRP will be prepared according to the manufacturer's instructions employing a Regen Autologous Cellular Regeneration (ACR®-C) Kit (Regen Laboratory, Le Mont-sur-Lausanne, Switzerland). Approximately 60 mL of the patient's peripheral blood will be required in order to yield the required volume of PRP. The goal concentration of platelets in PRP is approximately 1.000.000 platelets/µL. The technique of PRP intraovarian infusion resembles the transvaginal paracentesis performed during the oocyte pick-up procedure. Briefly, both ovaries are visualized via transvaginal ultrasound monitoring, and they are intramedullary injected on multiple sites using a 17-gauge single lumen needle, with the patient under inhaled minimal sedation.

Also known as: PRP

Experimental: Group of participants receiving PRP treatment

Eligibility Criteria

• Age: 35 Years - 47 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 and acupuncture, for at least three months prior to recruitment.
• Willing to comply with study requirements

You may not qualify if:

• 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 Preimplantation Genetic Testing (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

Sponsors & Collaborators

• Genesis Athens Clinic: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Genesis Athens Clinic

Athens, Attica, 15232, Greece

RECRUITING

MeSH Terms

Conditions

Infertility, Female; Infertility; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Agni Pantou, M.D

  Genesis Athens Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agni Pantou, M.D

CONTACT

+306974447702; agni.pantou@genesisathens.gr

Konstantinos Pantos, M.D., Ph.D

CONTACT

+302106894326; info@pantos.gr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental: Group of participants receiving PRP treatment Women presenting with POR, treated with autologous PRP intraovarian infusion in the mid-luteal phase of the menstrual cycle, undergoing a subsequent stimulated fresh Embryo Transfer-Intracytoplasmic Sperm Injection (ET-ICSI) cycle on the first menstrual cycle following PRP treatment. Control Group: Group of participants receiving standard management Women presenting with POR undergoing a stimulated fresh ET-ICSI cycle

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 6, 2022
• Study Start: January 23, 2019
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)