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The Efficacy of Platelets Rich Plasma for Ovarian Rejuvenation

Sponsor
Al-Kindy College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03946813
Collaborator
High Institute for Infertility Diagnosis and Assisted Reproductive Technologies (Other)
50
Enrollment
1
Location
1
Arm
9.3
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In recent years, an increased approach has appeared in the use of autologous blood products to assist tissue and organ healing. Application of platelet rich plasma (PRP) has emerged as a potential solution for infertile women with poor ovarian reserve in reproductive specialty.

Condition or Disease Intervention/Treatment Phase
  • Other: Autologous PRP preparation
 N/A

Detailed Description

Quantitative and qualitative functional improvement of ovarian function has been reported in several studies after using autologous PRP in a reproductive field. Ovarian rejuvenation, stimulating the ovaries to produce new eggs after injecting PRP, can offer hope for renewed fertility to women with poor reserve volume, advanced maternal age, or either naturally occurring or premature menopause. But, these encouraging results should be supported by several new studies.

This study aimed to estimate the efficacy of trans-vaginal ovarian injection with PRP in rejuvenates ovaries in woman with poor ovarian reserve, and to assess any association of some women variables (age, menstrual status, parity, BMI) as predicting factors in success of ovarian injection with PRP.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Platelets Rich Plasma (PRP) for Ovarian Rejuvenation
Actual Study Start Date :
Aug 20, 2018
Actual Primary Completion Date :
May 31, 2019
Actual Study Completion Date :
May 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Poor ovarian reserve

Infertile women with poor ovarian reserve

Other: Autologous PRP preparation
For each patient, autologous PRP preparation havs to be injected to both ovaries and ultrasound (US) guide
Other Names:
  • Plasma Rich Platelets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Follicle-stimulating hormone (FSH) concentration [4 weeks]

      Before after intervention measurement

    2. Anti-Müllerian hormone (AMH) concentration [4 weeks]

      Before after intervention measurement

    3. Antral follicles numbers [4 weeks]

      Before after intervention measurement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 49 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Menopause or peri-menopause under the age of 50.

    2. Premature ovarian insufficiency which is ovarian failure before the age of 40.

    3. Woman with primary ovarian failure of any cause.

    Exclusion Criteria:

    1. A previous injection with any medication, plasma, or PRP

    2. Invisible or difficult access ovaries.

    3. Medical disease or unfit for anesthesia patient.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 High Institute for Infertility Diagnosis and Assisted Reproductive Technologies Baghdad Iraq

    Sponsors and Collaborators

    • Al-Kindy College of Medicine
    • High Institute for Infertility Diagnosis and Assisted Reproductive Technologies

    Investigators

    • Study Director: Thuraya H Abdulla, Professor, Arab Board for Medical Specializations

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yousif Abdulraheem, Professor, Al-Kindy College of Medicine
    ClinicalTrials.gov Identifier:
    NCT03946813
    Other Study ID Numbers:
    • PRP
    First Posted:
    May 13, 2019
    Last Update Posted:
    Oct 29, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Yousif Abdulraheem, Professor, Al-Kindy College of Medicine
    Ovarian Rejuvenation , Infertility
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female

    Study Results

    No Results Posted as of Oct 29, 2019