Study of PRP in Women With Evidence of Diminished Ovarian Reserve

NCT04275700 | Completed

• 1 other identifier: 09182018-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of the study is that ovaries of women with a history of poor response to ovulation induction may benefit from exposure to growth factors known to be present in Platelet Rich Plasma (PRP). Since even ovaries from women with poor response still contain primordial follicles (which, however, no longer undergo recruitment), it is hoped that PRP injections into ovaries will activate follicular recruitment pathways and, subsequently, result in follicle growth. Should such growth be observed, follicles will be supported with routine daily gonadotropin stimulation until hCG trigger.

Conditions

Diminished Ovarian Reserve; Ovarian Failure

Keywords

Platelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

• Emergence of new ovarian follicles with evidence of estradiol production

  Emergence of new ovarian follicles greater than 4 mm in average diameter as measured using pelvic sonography with evidence of change estradiol serum estradiol levels as measured using a immuno assay.

  Change from baseline to 12 weeks

Secondary Outcomes (3)

• Change in serum AMH

  Change from baseline to 12 weeks

• Number of participants with retrieval of oocytes in an IVF cycle

  6 months

• Number of participants that establish a Clinical Pregnancy

  12 months

Study Arms (1)

A-PRP

EXPERIMENTAL

The cortex of each ovary will be injected with autologous platelet rich plasma.

Procedure: A-PRP

Interventions

A-PRP PROCEDURE

The cortex of each ovary will be injected with autologous platelet rich plasma. Up to seven different sites will be injected under ultrasound guidance. The patient will be under IV sedation.

Also known as: Autologous Platelet Rich Plasma

A-PRP

Eligibility Criteria

• Age: 21 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with failure to respond well to ovulation induction by having fewer than 1 cleavage stage embryo in response to past ovulation induction who do not qualify for the PRP4POI study
• Age 54 years and under.
• FSH \> 12
• AMH \< 1.1
• No Aspirin or Motrin for one week before treatment

You may not qualify if:

• Age \> 54 years
• 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.
• Relative contraindications for PRP
• Chronic liver diseases in the exacerbation phase
• Chronic intoxication against the background of long-term use of alcohol, addictive drugs, an administration of potent medications
• Use of steroidal anti-inflammatory drugs in less than 2 days before drawing the blood, an injection of corticosteroids in little less than 2 weeks before the procedure
• Pregnancy

Sponsors & Collaborators

• Center for Human Reproduction: lead

Study Sites (1)

Center For Human Reproduction

New York, New York, 10021, United States

Location

Related Publications (1)

• Barad DH, Albertini DF, Molinari E, Gleicher N. Preliminary report of intraovarian injections of autologous platelet-rich plasma (PRP) in extremely poor prognosis patients with only oocyte donation as alternative: a prospective cohort study. Hum Reprod Open. 2022 Jun 28;2022(3):hoac027. doi: 10.1093/hropen/hoac027. eCollection 2022.

  PMID: 35795849 BACKGROUND

Study Officials

• Norbert Gleicher, MD

  Medical Director

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No Masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each Ovary will be injected with A-PRP.

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: February 19, 2020
• Study Start: October 1, 2018
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)