New Approach for Ovarian PRP Injection for Poor Responders

October 26, 2024 updated by: Bassem Ayman Mahmoud Assaf

New Approach for Ovarian PRP Injection for Poor Responders ; Aiming At the Highest Response Rate

New Approach For Ovarian PRP Injection for poor responders

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Poor ovarian responders are at high risk of unsuccessful IVF/ICSI trials. In the last few years, many studies showed significant improvement of ovarian reserve parameters after PRP injection. There was no consensus regarding the route of injection, the volume injected, the location of PRP injection inside the ovary, the number of injection and the number of the cycle in which PRP is injected.

Study Type

Observational

Enrollment (Actual)

21

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

  • Egypt
      • Benha, Egypt, 13511
        • Benha 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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

women attending their attempt of IVF/ICSI at Assaf Fertility center, after poor ovarian response in a previous trial, during the period March 2024 to June 2025

Description

Inclusion Criteria:

  • AMH : < 0.5 ng/ml
  • FSH: > 10 miu but < 25 miu.
  • AFC : < 5 in both ovaries
  • Poor ovarian response, in a previous IVF/ICSI trial , resulting in 3 or fewer oocytes.
  • Normal uterine cavity , demonstrated by a recent hysteroscopy

Exclusion Criteria:

  • Primary ovarian insufficiency with FSH > 25 miu.
  • Previous ovarian surgery or Chemotherapy.
  • On going Anticoagulant use.
  • Carcinomas or a history of chronic pelvic pain.
  • Present infection.
  • Hemoglobin level lower than 11 g/L
  • platelet count lower than 150 x 10³/μL.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRP effect on ovary for better fertility outcome
Time Frame: one year
This is a prospective cohort clinical observational study. Aiming at evaluating the clinical effects of injecting PRP(Platelet Rich Plasma) into ovaries, of poor responders, taking all measures which may improve the response rate. That is why we will inject PRP for 2 consecutive cycles, the first cycle via laparoscopy and the next cycle, via ultrasonography.
one year

Collaborators and Investigators

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

Sponsor

Bassem Ayman Mahmoud Assaf

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 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

October 19, 2024

First Submitted That Met QC Criteria

October 26, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 26, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • New Approach For Ovarian PRP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

product manufactured in and exported from the U.S.

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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