NCT03946813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

May 6, 2023

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

May 6, 2019

Last Update Submit

May 3, 2023

Conditions

Infertility, Female

Keywords

Ovarian Rejuvenation , Infertility

Outcome Measures

Primary Outcomes (3)

  • Follicle-stimulating hormone (FSH) concentration

    Before after intervention measurement

    4 weeks

  • Anti-Müllerian hormone (AMH) concentration

    Before after intervention measurement

    4 weeks

  • Antral follicles numbers

    Before after intervention measurement

    4 weeks

Study Arms (1)

Poor ovarian reserve

EXPERIMENTAL

Infertile women with poor ovarian reserve

Other: Autologous PRP preparation

Interventions

Autologous PRP preparationOTHER

For each patient, autologous PRP preparation havs to be injected to both ovaries and ultrasound (US) guide

Also known as: Plasma Rich Platelets
Poor ovarian reserve

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsInfertile women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • A previous injection with any medication, plasma, or PRP
  • Invisible or difficult access ovaries.
  • Medical disease or unfit for anesthesia patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

High Institute for Infertility Diagnosis and Assisted Reproductive Technologies

Baghdad, Iraq

Location

Related Publications (1)

  • A

    RESULT

MeSH Terms

Conditions

Infertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Thuraya H Abdulla, Professor

    Arab Board for Medical Specializations

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 13, 2019

Study Start

August 20, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

May 6, 2023

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

All data will be managed confidentially

Locations

IR(1)