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Active, Not Recruiting

NCT Number: NCT04278313

Ovarian Function Following Intraovarian Injection of PRP

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diminished Ovarian Reserve Diminished Ovarian Reserve Due to Advanced Maternal Age

Age range

21 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Human Reproduction

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRP - Platelet Rich Plasma

Procedure

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

Procedure

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.

Primary outcomes

  1. Embryo Transfer

    Time frame: 6 weeks

    Number of participants with at least one day-3 embryo 8-cell with less than 5% fragmentation in an IVF cycle

Secondary outcomes

  1. Embryos Produced

    Time frame: 6 weeks

    Mean number of day-3 embryo 8-cell with less than 5% fragmentation produced

  2. AMH

    Time frame: 4 weeks

    Serum concentration of Anti Mullerian Hormone

  3. Antral Follicle Count

    Time frame: 4 weeks

    Number of Antral Follicles determined by pelvic sonogram on day 2 or 3 of menses

Other outcomes

  1. Pregnancy

    Time frame: 8 weeks

    Number of patients who Establish a Clinical Pregnancy (Fetal pole and positive evidence of fetal heart on pelvic sonogram)

Sponsors and collaborators

Lead sponsor

Center for Human Reproduction

Other

Registry information

Official study title

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

Acronym: PRP4POA

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2020
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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