The Efficacy of Platelets Rich Plasma for Ovarian Rejuvenation
Primary Purpose
Infertility, Female
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Autologous PRP preparation
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring Ovarian Rejuvenation , Infertility
Eligibility Criteria
Inclusion Criteria:
- Menopause or peri-menopause under the age of 50.
- Premature ovarian insufficiency which is ovarian failure before the age of 40.
- Woman with primary ovarian failure of any cause.
Exclusion Criteria:
- A previous injection with any medication, plasma, or PRP
- Invisible or difficult access ovaries.
- Medical disease or unfit for anesthesia patient.
Sites / Locations
- High Institute for Infertility Diagnosis and Assisted Reproductive Technologies
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Poor ovarian reserve
Arm Description
Infertile women with poor ovarian reserve
Outcomes
Primary Outcome Measures
Follicle-stimulating hormone (FSH) concentration
Before after intervention measurement
Anti-Müllerian hormone (AMH) concentration
Before after intervention measurement
Antral follicles numbers
Before after intervention measurement
Secondary Outcome Measures
Full Information
NCT ID
NCT03946813
First Posted
May 6, 2019
Last Updated
May 3, 2023
Sponsor
Al-Kindy College of Medicine
Collaborators
High Institute for Infertility Diagnosis and Assisted Reproductive Technologies
1. Study Identification
Unique Protocol Identification Number
NCT03946813
Brief Title
The Efficacy of Platelets Rich Plasma for Ovarian Rejuvenation
Official Title
The Efficacy of Platelets Rich Plasma (PRP) for Ovarian Rejuvenation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Kindy College of Medicine
Collaborators
High Institute for Infertility Diagnosis and Assisted Reproductive Technologies
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
Ovarian Rejuvenation , Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Poor ovarian reserve
Arm Type
Experimental
Arm Description
Infertile women with poor ovarian reserve
Intervention Type
Other
Intervention Name(s)
Autologous PRP preparation
Other Intervention Name(s)
Plasma Rich Platelets
Intervention Description
For each patient, autologous PRP preparation havs to be injected to both ovaries and ultrasound (US) guide
Primary Outcome Measure Information:
Title
Follicle-stimulating hormone (FSH) concentration
Description
Before after intervention measurement
Time Frame
4 weeks
Title
Anti-Müllerian hormone (AMH) concentration
Description
Before after intervention measurement
Time Frame
4 weeks
Title
Antral follicles numbers
Description
Before after intervention measurement
Time Frame
4 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Infertile women
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Menopause or peri-menopause under the age of 50.
Premature ovarian insufficiency which is ovarian failure before the age of 40.
Woman with primary ovarian failure of any cause.
Exclusion Criteria:
A previous injection with any medication, plasma, or PRP
Invisible or difficult access ovaries.
Medical disease or unfit for anesthesia patient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thuraya H Abdulla, Professor
Organizational Affiliation
Arab Board for Medical Specializations
Official's Role
Study Director
Facility Information:
Facility Name
High Institute for Infertility Diagnosis and Assisted Reproductive Technologies
City
Baghdad
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All data will be managed confidentially
Citations:
Citation
A
Results Reference
result
Learn more about this trial
The Efficacy of Platelets Rich Plasma for Ovarian Rejuvenation
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