Ovarian Function Following Intraovarian Injection of PRP

Diminished Ovarian Reserve Clinical Trial

— PRP4POA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04278313
• Other study ID #: 02102020-0
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2023
• Source: Center for Human Reproduction
• Contact: David Barad, MD
• Phone: 2018417587
• Email: dbarad[@]theCHR.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diminished Ovarian Reserve
• Diminished Ovarian Reserve Due to Advanced Maternal Age

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for Human Reproduction	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Center for Human Reproduction

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pregnancy	Number of patients who Establish a Clinical Pregnancy (Fetal pole and positive evidence of fetal heart on pelvic sonogram)	8 weeks
Primary	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	Embryos Produced	Mean number of day-3 embryo 8-cell with less than 5% fragmentation produced	6 weeks
Secondary	AMH	Serum concentration of Anti Mullerian Hormone	4 weeks
Secondary	Antral Follicle Count	Number of Antral Follicles determined by pelvic sonogram on day 2 or 3 of menses	4 weeks