Autologous Intraovarian Platelet Rich Plasma Treatment in Women With Poor Ovarian Response

April 5, 2022 updated by: Nadezhda Women's Health Hospital

Effects of Autologous Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response

Reproductive age women diagnosed with poor ovarian response (POR) based on Bologna criteria with a history of at least two prior failed ICSI 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 both ovaries. Ovarian reserve parameters and ICSI outcomes will be determined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Reproductive age women diagnosed with POR based on Bologna criteria with a history of at least two prior failed intracytoplasmic sperm injection (ICSI) 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 11.8 inch (30 cm) single lumen 21G needles under transvaginal ultrasound guidance. On the 2 to 4th days of the first three 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 ICSI, followed by embryo transfer. Biomarkers of ovarian reserve (AFC, FSH, AMH), and ICSI outcome parameters (number of metaphase II (MII) oocytes, blastocyst embryos, fertilization rate, oocyte and embryo quality) will be followed.

Study Type

Interventional

Enrollment (Actual)

66

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

  • Bulgaria
      • Sofia, Bulgaria, 1373
        • Nadezhda Women's Health Hospital

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

28 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients diagnosed with POR based on Bologna criteria and with a history of at least two prior failed ICSI cycles
  • A previous assisted reproductive technology cycle with less than 3 oocytes (conventional stimulation protocol) and AFC < 7
  • The same ovarian stimulation protocol before and after the PRP treatment

Exclusion Criteria:

  • Age over 46 years,
  • Body mass index (BMI) ≥ 30 kg/m2,
  • Presence of pregnancy
  • Uncontrolled endocrine disorders (polycystic ovary syndrome and others)
  • Parental genetic and chromosomal disorders,
  • Immunological disorders
  • Cancer diagnostics

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: Autologous ovarian PRP injection
The same day, within 1 hour of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into both ovaries using 11.8 inch (30 cm) single lumen 21G needles. The ovaries will be reached using needle guide preventing vascular or other structures rupture. The needle will be advanced into the centre of the ovarian medula without rotation. The correct tip placement will be confirmed by ultrasound. The activated PRP will be slowly introduced during careful retraction of the needle across the previously traversed ovarian cortex. The final PRP volume will be deposited under the ovarian capsule and the needle exit the ovary. Approximately 0.5 ml 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 minutes and also be discharged home on the same day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte number
Time Frame: 3 months
Number of Metaphase II oocyte yield.
3 months
Oocyte quality
Time Frame: 3 months
Oocytes will be classified based on morphological assessment and enumeration of extracytoplasmic anomalies.
3 months
Embryo number
Time Frame: 3 months
Number of produced embryos per cycle.
3 months
Embryo quality
Time Frame: 3 months
Morphological evaluation of the cultured embryos will be conducted 120 or 144 hr following sperm injection. Blastocysts scoring will be performed on day 5 or 6 depending on the blastocoel cavity expansion and on the inner cell mass and trophectoderm cells integrity.
3 months
Fertilization rate
Time Frame: 3 months
Fertilization rate will be calculated as the percentage of transformation of the injected oocytes into two pronuclei.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antral follicle count (AFC)
Time Frame: 3 months
Number of Antral Follicles determined by pelvic sonogram on day 2 or 3 of the cycle.
3 months
Serum anti-mullerian hormone (AMH)
Time Frame: 3 months
Serum concentration of anti-mullerian hormone determined on day 3 of the cycle by an electrochemiluminescent (ECLIA) immunoanalyzer.
3 months
Serum follicle stimulating hormone (FSH)
Time Frame: 3 months
Serum concentration of follicle stimulating hormone (FSH) levels determined on day 3 of the cycle by an electrochemiluminescent (ECLIA) immunoanalyzer.
3 months

Collaborators and Investigators

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

Sponsor

Nadezhda Women's Health Hospital

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)

March 16, 2021

Primary Completion (Actual)

September 4, 2021

Study Completion (Actual)

September 4, 2021

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 022019

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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