Back to resultsPlatelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency
Primary Purpose
Premature Ovarian Failure
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ovarian Failure focused on measuring Premature ovarian insuffiency, Infertility, PRP
Eligibility Criteria
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
Sites / Locations
- Adel Elgergawy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRP injection
Arm Description
injection of PRP inside ovary by the assistance of laparoscopy
Outcomes
Primary Outcome Measures
Resumption of ovarian hormonal function
Measurement of Estradiol level on Day 3 of cycle
Resumption of ovarian folliclugenesis
Assessment of the presence of oocytes by trans vaginal ultrasound on day 3
Secondary Outcome Measures
Resumption of menstruation
Occurrence of Menstruation after secondary amenrorrhea by questionnaire
Fertility potential
Potential to get pregnant after ICSI procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04149028
Brief Title
Platelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency
Official Title
Platelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure
Keywords
Premature ovarian insuffiency, Infertility, PRP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All eligible patient will recieve the treatment with PRP
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP injection
Arm Type
Experimental
Arm Description
injection of PRP inside ovary by the assistance of laparoscopy
Intervention Type
Procedure
Intervention Name(s)
PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml
Intervention Description
intraovarian injection of 2 mml of PRP by laparoscopic guide
Primary Outcome Measure Information:
Title
Resumption of ovarian hormonal function
Description
Measurement of Estradiol level on Day 3 of cycle
Time Frame
3-6 months
Title
Resumption of ovarian folliclugenesis
Description
Assessment of the presence of oocytes by trans vaginal ultrasound on day 3
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Resumption of menstruation
Description
Occurrence of Menstruation after secondary amenrorrhea by questionnaire
Time Frame
3-6 months
Title
Fertility potential
Description
Potential to get pregnant after ICSI procedure
Time Frame
3-6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Adel Elgergawy
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
we will decide later
Learn more about this trial
Platelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency
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