Effects of Platelet Rich Plasma on Endometrium

Effects of Intrauterine Platelet Rich Plasma (PRP) on Endometrium and Pregnancy Rates in Patients With Suboptimal Endometrium Undergoing Frozen Embryo Transfer

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.

Study Overview

• Status: Completed
• Conditions: Asherman Syndrome
• Intervention / Treatment: Biological: PRP injection in the endometrium

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34460
    • Acıbadem Maslak Hospital IVF Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endometrial PRP; Patients in whom endometrial PRP was performed

Biological: PRP injection in the endometrium; Within 5 days after the cessation of menstrual period, endometrial PRP procedure will be planned. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into the endometrial region of the endometrium in several positions.On the same day after the procedure, the patient will be observed in the outpatient room and will be discharged on the same day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial thickness during hormone replacement therapy	To measure endometrial thickness assessed by ultrasound during hormone replacement therapy for endometrial preparation in frozen-thawed cycles	2-10 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Acibadem University
• Collaborators: Baskent University
• Investigators: Study Director: Yigit Cakiroglu, Assoc.Prof., Acibadem University; Principal Investigator: Hulusi Bulent Zeyneloglu, Prof, Baskent University Departments of Obstetrics and Gynecology

Publications and helpful links

General Publications

• Chang Y, Li J, Chen Y, Wei L, Yang X, Shi Y, Liang X. Autologous platelet-rich plasma promotes endometrial growth and improves pregnancy outcome during in vitro fertilization. Int J Clin Exp Med. 2015 Jan 15;8(1):1286-90. eCollection 2015.
• Tandulwadkar SR, Naralkar MV, Surana AD, Selvakarthick M, Kharat AH. Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. J Hum Reprod Sci. 2017 Jul-Sep;10(3):208-212. doi: 10.4103/jhrs.JHRS_28_17.
• Zadehmodarres S, Salehpour S, Saharkhiz N, Nazari L. Treatment of thin endometrium with autologous platelet-rich plasma: a pilot study. JBRA Assist Reprod. 2017 Feb 1;21(1):54-56. doi: 10.5935/1518-0557.20170013.
• Chang Y, Li J, Wei LN, Pang J, Chen J, Liang X. Autologous platelet-rich plasma infusion improves clinical pregnancy rate in frozen embryo transfer cycles for women with thin endometrium. Medicine (Baltimore). 2019 Jan;98(3):e14062. doi: 10.1097/MD.0000000000014062.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): April 19, 2021
• Study Completion (Actual): April 19, 2021

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 6, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gynatresia
• Other Study ID Numbers: KA20/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No