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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04149028
Other study ID # POFPRP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date December 31, 2022

Study information

Verified date February 2023
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

All encountered cases with POI will be assessed and examined then investigated. Eligible cases will be included in the study


Description:

Patients will be subjected to injection of autologous PRP inside the ovary about 0.5-1 mml by laparoscopy


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Intervention

Procedure:
PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml
intraovarian injection of 2 mml of PRP by laparoscopic guide

Locations

Country Name City State
Egypt Adel Elgergawy Tanta

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resumption of ovarian hormonal function Measurement of Estradiol level on Day 3 of cycle 3-6 months
Primary Resumption of ovarian folliclugenesis Assessment of the presence of oocytes by trans vaginal ultrasound on day 3 3-6 months
Secondary Resumption of menstruation Occurrence of Menstruation after secondary amenrorrhea by questionnaire 3-6 months
Secondary Fertility potential Potential to get pregnant after ICSI procedure 3-6 months
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