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

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ClinicalTrials.gov Identifier: NCT04149028
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Ayman S Dawood, MD, Tanta University

Tracking Information
First Submitted Date  ICMJE October 30, 2019
First Posted Date  ICMJE November 4, 2019
Last Update Posted Date May 25, 2021
Actual Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
  • Resumption of ovarian hormonal function [ Time Frame: 3-6 months ]
    Measurement of Estradiol level on Day 3 of cycle
  • Resumption of ovarian folliclugenesis [ Time Frame: 3-6 months ]
    Assessment of the presence of oocytes by trans vaginal ultrasound on day 3
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
  • Resumption of menstruation [ Time Frame: 3-6 months ]
    Occurrence of Menstruation after secondary amenrorrhea by questionnaire
  • Fertility potential [ Time Frame: 3-6 months ]
    Potential to get pregnant after ICSI procedure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Platelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency
Official Title  ICMJE Platelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency
Brief Summary All encountered cases with POI will be assessed and examined then investigated. Eligible cases will be included in the study
Detailed Description Patients will be subjected to injection of autologous PRP inside the ovary about 0.5-1 mml by laparoscopy
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All eligible patient will recieve the treatment with PRP
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Premature Ovarian Failure
Intervention  ICMJE Procedure: PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml
intraovarian injection of 2 mml of PRP by laparoscopic guide
Study Arms  ICMJE Experimental: PRP injection
injection of PRP inside ovary by the assistance of laparoscopy
Intervention: Procedure: PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adel Elgergawy +201002057250 dradelali775@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04149028
Other Study ID Numbers  ICMJE POFPRP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: we will decide later
Responsible Party Ayman S Dawood, MD, Tanta University
Study Sponsor  ICMJE Tanta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tanta University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP