Ovarian Function Following Intraovarian Injection of PRP

NCT04278313 | Active Not Recruiting

• 1 other identifier: 02102020-0
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Infertility - Ovarian dysfunuction; Diminished Ovarian Reserve; Premature Ovarian Aging (POA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Embryos Produced

  6 weeks

• AMH

  4 weeks

• Antral Follicle Count

  4 weeks

Other Outcomes (1)

• Pregnancy

  8 weeks

Study Arms (2)

PRP group

EXPERIMENTAL

Platelet RICH Plasma prepared using RegenLab FDA approved device.

Procedure: PRP - Platelet Rich Plasma

PPP group

PLACEBO COMPARATOR

Platelet POOR Plasma prepared using RegenLab FDA approved device.

Procedure: PPP - Platelet Poor Plasma

Interventions

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.

PRP group

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.

PPP group

Eligibility Criteria

• Age: 21 Years - 44 Years
• Gender Eligibility Details: Must have ovaries and desire to establish a pregnancy using IVF
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Human Reproduction: lead

Study Sites (1)

Center for Human Reproduction

New York, New York, 10021, United States

Location

Study Officials

• David H Barad, MD

  Center for Human Reproduction

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP)

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: February 24, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)