NCT04149028

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration 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

First Submitted

Initial submission to the registry

October 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

October 30, 2019

Last Update Submit

February 16, 2023

Conditions

Premature Ovarian Failure

Keywords

Premature ovarian insuffiencyInfertilityPRP

Outcome Measures

Primary Outcomes (2)

  • Resumption of ovarian hormonal function

    Measurement of Estradiol level on Day 3 of cycle

    3-6 months

  • Resumption of ovarian folliclugenesis

    Assessment of the presence of oocytes by trans vaginal ultrasound on day 3

    3-6 months

Secondary Outcomes (2)

  • Resumption of menstruation

    3-6 months

  • Fertility potential

    3-6 months

Study Arms (1)

PRP injection

EXPERIMENTAL

injection of PRP inside ovary by the assistance of laparoscopy

Procedure: PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml

Interventions

PRP injection inside the ovary by laparoscoy. The injection volume is 2 mlPROCEDURE

intraovarian injection of 2 mml of PRP by laparoscopic guide

PRP injection

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premature ovarian insufficiency diagnosed by:
  • FSH\> 40 Amenorrhea Menopuasal symptoms Infertility

You may not qualify if:

  • Refusal to participate Secondary POI due chemotherapy, surgery, or radiotherapy Previous treatment with PRP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adel Elgergawy

Tanta, Egypt

Location

MeSH Terms

Conditions

Primary Ovarian InsufficiencyInfertility

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All eligible patient will recieve the treatment with PRP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and gynecology

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 4, 2019

Study Start

December 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

EG(1)