Intrauterine Autologous PRP Infusion Compared to HRT for Enhancing Endometrial Thickness in Patients Undergoing ICSI

• Sponsor: Ain Shams University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02660294
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

Successful embryo implantation needs an optimum embryonic development with a receptive endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison with standard hormonal therapy.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Biological: platlet rich plasma	Phase 1/Phase 2

Detailed Description

This is a single blinded randomized trial comparing the effect of of platlet rich plasma versus hormonal therapy on endometrial thickness and consequently endometrial receptivity. The primary endpoint of this trial is clinical pregnancy rate.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intrauterine Autologous Platelet -Enriched Plasma Infusion Compared to Hormonal Replacement Therapy for Enhancing Endometrial Thickness in Patients Undergoing ICSI
• Study Start Date: Mar 1, 2016
• Anticipated Primary Completion Date: Mar 1, 2017
• Anticipated Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Platlet rich plasma For those with endometrial thickness less than 7 mm intrauterine injection of platlet rich plasma (PRP) for enhancing endometrial thickness and receptivity	Biological: platlet rich plasma; Platelet-rich plasma (PRP) is prepared from fresh whole blood which is collected from a peripheral vein, stored in acid citrate dextrose solution A (ACD-A) anticoagulant and processed to increase platelets by separating various components of blood
No Intervention: Hormone replacement therapy Oral intake of estradiol valerate for those with endometrial thickness less than 7 mm will improve endometrial receptivity

Outcome Measures

Primary Outcome Measures

1. endometrial thickness in mm [72 hours]

   using transvaginal ultrasound to measure endometrial thickness in mm

Secondary Outcome Measures

1. clinical pregnancy rate [4 weeks after embryo transfer]

   using transvaginal ultrasound to detect fetal cardiac activity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients undergoing ICSI

• endometrial thickness less than 7 mm on early follicular phase

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rasha	Cairo	Al Qahirah	Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

• Principal Investigator: RASHA DR MEDHAT, MD, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: rasha medhat abdul-hady, DR. Rasha Medhat Abdul-hady, Ain Shams University
• ClinicalTrials.gov Identifier: NCT02660294
• Other Study ID Numbers: PRP-IVF
• First Posted: Jan 21, 2016
• Last Update Posted: Mar 22, 2016
• Last Verified: Mar 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Mar 22, 2016