Injections of Autologous PRP in Women With Primary Ovarian Insufficiency (PRP4POI)

Prospectively Randomized Study of Intraovarian Injections of Autologous Platelet-rich Plasma (PRP) in Women With Primary Ovarian Insufficiency (POI)

Premature ovarian failure is a loss of normal function before age 40, leading to infertility and hypoestrogenism. This study will involve only adult women with a diagnosis of POI. Participants will receive injections of autologous PRP in one randomly selected ovary.

Study Overview

• Status: Completed
• Conditions: Primary Ovarian Insufficiency; Premature Menopause
• Intervention / Treatment: Procedure: A-PRP

Detailed Description

Premature ovarian failure is a loss of normal function before age 40, leading to infertility and hypoestrogenism. While POI is sometimes called premature menopause, it is not the same thing as menopause. Women with POI may still have occasional irregular periods and may even occasionally achieve a pregnancy. Symptoms of POI include: irregular menses or amenorrhea, infertility, hypoestrogenic symptoms and decreased libido. POI may be caused by Chromosomal defects such as mosaic Turner's syndrome, exposure to toxins (chemotherapy or radiation), autoimmunity, genetic factors (FMR1) and other unknown factors.

Autologous Platelet Rich Plasma (A-PRP) is plasma with a concentration of platelets above the blood baseline. A-PRP is developed from autologous blood. Within A-PRP, the concentration of platelets delivers an increased number of growth factors. In this study A-PRP will be prepared using Regen Lab PRP Kit which is approved by US-FDA for preparation of PRP.

PRP is becoming widely used in a variety of medical procedures seeking tissue remodeling and/or healing as an intervention. To date, applications in orthopedics, wound healing, dermatology and plastic surgery have gained general acceptance, primarily as the role of platelets and their activation in tissue repair and recovery has become better understood at a cellular and molecular level. This knowledge base provides a foundation for the present study because of the ready availability of FDA-approved kits for autologous PRP preparations and the recognition that the aging ovary acquires tissue pathologies in the form of wound healing and fibrosis as a result of repeat ovulations over the reproductive lifespan of women. Since PRP is an autologous blood product, and is widely used via injection into various organs and tissues, safety concerns are minimal.

This study will involve only adult women with a diagnosis of POI. Consenting participants will receive injections of autologous Platelet RIch Plasma (A-PRP) in one randomly selected ovary under ultrasound guidance performed after induction of IV sedation. Randomization will determine whether the right or left ovary will be treated. The result of randomization will not be recorded in the participants clinical chart, but will be maintained in the research database with blinding to all clinical participants. The physician performing the A-PRP administration will not perform post procedure follow-up of those patients. In case of a complication, possibly related to treatment, the case will be unblinded.

The study will be powered to detect a 20% response in the treated ovary (every patient's 2nd ovary will serve as control). This will require 68 ovaries and 34 patients. The study, thus, does not involve randomization of patients because each patient's second ovary functions as control ovary, although which ovary will receive treatment in a given patient will be determined by computer randomization.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Barad, MD; Phone Number: 212 944-4400; Email: dbarad@theCHR.com
• Study Contact Backup: Name: Jolanta Tapper; Phone Number: 212 994-4400; Email: jtapper@theCHR.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Center For Human Reproduction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Signed and dated informed consent
• Women 40 years of age and younger with documented primary ovarian insufficiency.
• Normal Karyotype
• FSH > 30
• AMH not detectable
• No evidence of follicles > 4mm
• Must have two ovaries of approximately equal volume.
• No Aspirin or any NSAID (e.g. Motrin) for approximately one week before treatment
• Willingness to undergo further fertility treatment, including IVF if there is evidence of response

Exclusion Criteria:

• Premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality
• Marked thrombocytopenia
• Blood diseases
• Hypofibrinogenemia
• Hemodynamic instability
• Anticoagulant or antiaggregant treatment
• Oncological diseases (specially, skeletal system and blood)
• Sepsis
• Acute and chronic infectious diseases
• Autoimmune diseases, for example, lupus erythematosus, etc.
• Active substance abuse or dependence
• Major Mental health disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-PRP; The cortex of selected ovary will be injected with autologous platelet rich plasma.	Procedure: A-PRP; The cortex of selected ovary will be injected with autologous platelet rich plasma. Up to ten different sites will be injected under ultrasound guidance. The patient will be under IV sedation. Record of which ovary was injected will be kept in the online research database and not in the clinical chart.; Other Names: Autologous Platelet Rich Plasma
No Intervention: Control; The contralateral ovary will not be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ovarian Follicles	Emergence of new ovarian follicles with evidence of estradiol production	Change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in serum AMH	Increase in serum AMH above baseline level	Change from baseline to 12 weeks
Retrieval of oocytes in an IVF cycle	Retrieval of oocytes in an IVF cycle	6 months
Clinical Pregnancy	Establishment of a Clinical pregnancy,	12 months

Collaborators and Investigators

• Sponsor: Center for Human Reproduction
• Investigators: Principal Investigator: Norbert Gleicher, MD, Medical Director

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2018
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (Actual): May 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: 03192018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share individual patient data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No