Ovarian Function Following Intraovarian Injection of PRP (PRP4POA)

Randomized Controlled Trial of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma for Women With Ovarian Aging

Consenting women with evidence of poor ovarian reserve will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP).

Study Overview

• Status: Active, not recruiting
• Conditions: Diminished Ovarian Reserve; Diminished Ovarian Reserve Due to Advanced Maternal Age
• Intervention / Treatment: Procedure: PRP - Platelet Rich Plasma; Procedure: PPP - Platelet Poor Plasma

Detailed Description

As women age oocytes are gradually depleted with a consequent progressive loss of ovarian function and fertility. When a woman's follicle cohort falls below a critical level, she enters a transitional time of diminished ovarian reserve known as ovarian aging. Recently the use of autologous platelet-rich plasma (A-PRP) has been proposed as an additional strategy for improving ovarian function. A-PRP is prepared from autologous blood using an FDA approved device. The rationale for the use of PRP is that it contains growth factors which stimulate cellular anabolism, inflammatory modulators that create an anti-inflammatory effect and fibrinogen which acts as a scaffold for regenerating tissue. The investigators hypothesize that the growth factors present in PRP may have a beneficial effect promoting growth and recruitment of antral follicles. The investigators will recruit a prospective cohort of 90 patients with evidence of Premature Ovarian Aging/DOR. Women invited to participate in this RCT will have FSH above 12 and AMH below 1.0 ng/mL respectively and will have had fewer than 6 oocytes retrieved in a previous ovulation attempt. Consenting participants in this trial will be randomized in a doubly blind fashion to two groups. One will receive Platelet Rich Plasma (PRP) and the other will receive Platelet Poor Plasma (PPP). Women assigned to PPP will be offerred PRP in a future cycle if they so desire.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

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: 17 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• fewer than 6 oocytes in response to past ovulation induction
• desire to establish a pregnancy using IVF
• Age 44 years and under.
• FSH > 12
• AMH < 1.0
• No Aspirin or Motrin for one week before treatment

Exclusion Criteria:

• Age > 45 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP group; Platelet RICH Plasma prepared using RegenLab FDA approved device.	Procedure: PRP - Platelet Rich Plasma; Using a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube to leave 2.5 ml of Platelet Rich Plasma in the tube. The tube is inverted several times to suspend the platelet pellet. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room.
Placebo Comparator: PPP group; Platelet POOR Plasma prepared using RegenLab FDA approved device.	Procedure: PPP - Platelet Poor Plasma; Using a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube. The prepared plasma will be transported to the procedure room. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Embryo Transfer	Number of participants with at least one day-3 embryo 8-cell with less than 5% fragmentation in an IVF cycle	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Embryos Produced	Mean number of day-3 embryo 8-cell with less than 5% fragmentation produced	6 weeks
AMH	Serum concentration of Anti Mullerian Hormone	4 weeks
Antral Follicle Count	Number of Antral Follicles determined by pelvic sonogram on day 2 or 3 of menses	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	Number of patients who Establish a Clinical Pregnancy (Fetal pole and positive evidence of fetal heart on pelvic sonogram)	8 weeks

Collaborators and Investigators

• Sponsor: Center for Human Reproduction
• Investigators: Principal Investigator: David H Barad, MD, Center for Human Reproduction

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Diminished Ovarian Reserve; Infertility - Ovarian dysfunuction; Premature Ovarian Aging (POA)
• Other Study ID Numbers: 02102020-0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

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