Effects of Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response and Premature Ovarian Insufficiency

November 21, 2020 updated by: Bulent Tiras, Acibadem University

Effects of Intraovarian Injection of Autologous Platelet Rich Plasma on Ovarian Reserve and IVF Outcome Parameters in Women With Premature Ovarian Insufficiency and Poor Ovarian Response

Reproductive age women diagnosed with poor ovarian response (POR) based on Poseidon criteria and premature ovarian insufficiency (POI) based on ESHRE criteria and with a history of at least one prior failed IVF cycle will be recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols and will be injected to at least one ovary. Ovarian reserve parameters and IVF outcomes will be determined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Reproductive age women diagnosed with POR based on Poseidon criteria and POI based on European Society of Human Reproduction and Endocrinology (ESHRE) criteria with a history of at least one prior failed IVF cycle will recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will be determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under sedation anesthesia, using a 35 cm 17 G needle under transvaginal ultrasound guidance. On the 2-4th days of the first six menstrual cycles following the procedure, AFC, AMH, and FSH levels will be re-assessed. Patients with at least one antral follicle will be started on ovarian stimulation for in-vitro fertilization- intracytoplasmic sperm injection (IVF-ICSI), followed by embryo banking/ preimplantation genetic testing- aneuploidy (PGT-A) or embryo transfer. Markers of ovarian reserve (AFC, FSH, AMH), and IVF laboratory outcome parameters (number of metaphase II (MII) oocytes, 2PN(pronucleus) embryos, cleavage stage, blastocyst embryos) will be followed.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34752
        • Acıbadem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with a history of >1 year infertility duration with at least one ovary, who fulfilled the ESHRE criteria,
  • Patients diagnosed with POR based on Poseidon criteria and with a history of at least one prior failed IVF cycle

Exclusion Criteria:

  • Presence of pregnancy,
  • previous diagnosis of any malignancy,
  • ovarian insufficiency secondary to sex chromosome etiology,
  • prior major lower abdominal surgery resulting in pelvic adhesions,
  • anticoagulant use for which plasma infusion is contraindicated,
  • current or previous (Immunoglobulin A (IgA) deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ovarian Reserve
Patients with diminished ovarian reserve or premature ovarian insufficiency
Biological: PRP injection into at least one ovary
The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into at least one ovary using a 35 cm 17 G single lumen needle. The injection will be done underneath the ovarian cortex to the subcortical and stromal areas. Approximately 2-4cc of the PRP solution will be injected into each ovary. After the procedure, the patients will be taken to the recovery room and will be observed for 30-40 minutes and also be discharged home on the same day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian reserve parameters
Time Frame: 6 months
Number of participants with intraovarian injection of autologous PRP as assessed by blood hormone analysis and ultrasonographic antral follicle counts, change in serum FSH, AMH levels and number of antral follicle counts.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian response to stimulation
Time Frame: 12 months
Number of participants with intraovarian injection of autologous PRP as assessed by number antral follicle counts on ultrasound, eggs, and embryos in the laboratory, change from baseline in number of developing follicles, and percentage of obtained eggs and fertilized embryos.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
IVF outcomes
Time Frame: 15 months
Number of participants with ovarian PRP as assessed by number of clinical pregnancies, change in the percentage of clinical pregnancy rates with IVF treatment.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Study Director: Yigit Cakiroglu, Assoc.Prof., Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2020

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

November 21, 2020

Study Registration Dates

First Submitted

January 12, 2020

First Submitted That Met QC Criteria

January 19, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 21, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK 2019/8-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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