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

• Sponsor: Tanta University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04149028
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Premature Ovarian Failure	Procedure: PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All eligible patient will recieve the treatment with PRPAll eligible patient will recieve the treatment with PRP
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Platelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency
• Actual Study Start Date: Dec 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRP injection injection of PRP inside ovary by the assistance of laparoscopy	Procedure: PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml; intraovarian injection of 2 mml of PRP by laparoscopic guide

Outcome Measures

Primary Outcome Measures

1. Resumption of ovarian hormonal function [3-6 months]

   Measurement of Estradiol level on Day 3 of cycle

2. Resumption of ovarian folliclugenesis [3-6 months]

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

Secondary Outcome Measures

1. Resumption of menstruation [3-6 months]

   Occurrence of Menstruation after secondary amenrorrhea by questionnaire

2. Fertility potential [3-6 months]

   Potential to get pregnant after ICSI procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adel Elgergawy	Tanta		Egypt

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ayman S Dawood, MD, Lecturer of Obstetrics and gynecology, Tanta University
• ClinicalTrials.gov Identifier: NCT04149028
• Other Study ID Numbers: POFPRP
• First Posted: Nov 4, 2019
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ayman S Dawood, MD, Lecturer of Obstetrics and gynecology, Tanta University: Premature ovarian insuffiency; Infertility; PRP
• Additional relevant MeSH terms: Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature

Study Results

No Results Posted as of Apr 20, 2022