Platelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency

February 16, 2023 updated by: Ayman S Dawood, MD, Tanta University
All encountered cases with POI will be assessed and examined then investigated. Eligible cases will be included in the study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be subjected to injection of autologous PRP inside the ovary about 0.5-1 mml by laparoscopy

Study Type

Interventional

Enrollment (Actual)

16

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 Contact

Study Locations

  • Egypt
      • Tanta, Egypt
        • Adel Elgergawy

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premature ovarian insufficiency diagnosed by:
  • FSH> 40 Amenorrhea Menopuasal symptoms Infertility

Exclusion Criteria:

  • Refusal to participate Secondary POI due chemotherapy, surgery, or radiotherapy Previous treatment with PRP

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: PRP injection
injection of PRP inside ovary by the assistance of laparoscopy
Procedure: PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml
intraovarian injection of 2 mml of PRP by laparoscopic guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resumption of ovarian hormonal function
Time Frame: 3-6 months
Measurement of Estradiol level on Day 3 of cycle
3-6 months
Resumption of ovarian folliclugenesis
Time Frame: 3-6 months
Assessment of the presence of oocytes by trans vaginal ultrasound on day 3
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resumption of menstruation
Time Frame: 3-6 months
Occurrence of Menstruation after secondary amenrorrhea by questionnaire
3-6 months
Fertility potential
Time Frame: 3-6 months
Potential to get pregnant after ICSI procedure
3-6 months

Collaborators and Investigators

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

Sponsor

Tanta University

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)

December 1, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POFPRP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

we will decide later

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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