Effects of Platelet Rich Plasma on Endometrium

Not Applicable

Completed

• Conditions: Asherman Syndrome
• Interventions: Biological: PRP injection in the endometrium

• Registration Number: NCT04424160
• Lead Sponsor: Acibadem University

Brief Summary

Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. The endometrial thickness will be assessed under ultrasound and hormone replacement will be started. As the endometrial thickness reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed.

Detailed Description

Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. In the second menstrual period following the PRP injection, the endometrial thickness will be assessed under ultrasound and hormone replacement will be started. As the endometrial thickness reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed. Pregnancy test results will be recorded and followed.

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-06
• Study First Posted: 2020-06-09
• Study Start: 2020-09-15
• Status Verified: 2021-04
• Primary Completion: 2021-04-19
• Study Completion: 2021-04-19
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Women in whom cycle was cancelled due to an endometrial thickness <7 mm when progesterone start was planned in patients undergoing frozen embryo transfer with hormone replacement therapy
• Women with a history of Asherman syndrome, but no obvious intrauterine adhesion in the last hysteroscopic procedure;
• Women who have at least 2 frozen good-quality embryos.

Exclusion Criteria

• Women with any other known cause of implantation failure, such as poor embryo quality, or congenital uterine anomalies, endometrial polyp or fibroid,
• Previous diagnosis of any malignancy,
• Anticoagulant use for which plasma infusion is contraindicated,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endometrial PRP	PRP injection in the endometrium	Patients in whom endometrial PRP was performed

Primary Outcome Measures

Name	Time	Method
Endometrial thickness during hormone replacement therapy	2-10 months	To measure endometrial thickness assessed by ultrasound during hormone replacement therapy for endometrial preparation in frozen-thawed cycles

Secondary Outcome Measures

Name	Time	Method
Pregnancy outcomes after frozen-thawed embryo transfer	2-10 months	To assess pregnancy rates by beta-human chorionic gonadotropin and ultrasound after frozen-thawed embryo transfer cycles

Trial Locations

Locations (1)

Acıbadem Maslak Hospital IVF Unit; 🇹🇷 Istanbul, Turkey