Ovarian Function Following Intraovarian Injection of PRP

Not Applicable

Recruiting

• Conditions: Diminished Ovarian Reserve Due to Advanced Maternal Age; Diminished Ovarian Reserve
• Interventions: Procedure: PPP - Platelet Poor Plasma; Procedure: PRP - Platelet Rich Plasma

• Registration Number: NCT04278313
• Lead Sponsor: Center for Human Reproduction

Brief 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).

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 Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Study Start: 2020-02-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
PPP group	PPP - Platelet Poor Plasma	Platelet POOR Plasma prepared using RegenLab FDA approved device.
PRP group	PRP - Platelet Rich Plasma	Platelet RICH Plasma prepared using RegenLab FDA approved device.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center for Human Reproduction; 🇺🇸 New York, New York, United States