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Ovarian Function Following Intraovarian Injection of PRP (PRP4POA)

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ClinicalTrials.gov Identifier: NCT04278313
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Diminished Ovarian Reserve Diminished Ovarian Reserve Due to Advanced Maternal Age Procedure: PRP - Platelet Rich Plasma Procedure: PPP - Platelet Poor Plasma Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Participants will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma for Women With Ovarian Aging
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 2022

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must have ovaries and desire to establish a pregnancy using IVF
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278313


Contacts
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Contact: David Barad, MD 2018417587 dbarad@theCHR.com
Contact: Norbert Gleicher, MD 212 994-4400 ngleicher@theCHR.com

Locations
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United States, New York
Center for Human Reproduction Recruiting
New York, New York, United States, 10021
Contact: Jolanta Tapper    212-994-4400    jtapper@theCHR.com   
Principal Investigator: David Barad, MD, MS         
Sub-Investigator: Norbert Gleicher, MD         
Sponsors and Collaborators
Center for Human Reproduction
Investigators
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Principal Investigator: David H Barad, MD Center for Human Reproduction
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Responsible Party: Center for Human Reproduction
ClinicalTrials.gov Identifier: NCT04278313    
Other Study ID Numbers: 02102020-0
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Center for Human Reproduction:
Infertility - Ovarian dysfunuction
Diminished Ovarian Reserve
Premature Ovarian Aging (POA)