Effects of Platelet Rich Plasma on Endometrium

NCT04424160 | Completed

• 1 other identifier: KA20/23
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Asherman Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pregnancy outcomes after frozen-thawed embryo transfer

  2-10 months

Study Arms (1)

Endometrial PRP

EXPERIMENTAL

Patients in whom endometrial PRP was performed

Biological: PRP injection in the endometrium

Interventions

PRP injection in the endometrium BIOLOGICAL

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.

Endometrial PRP

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: All infertile women desiring pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Acibadem University: lead
• Baskent University: collaborator

Study Sites (1)

Acıbadem Maslak Hospital IVF Unit

Istanbul, 34460, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 25785127 RESULT

• 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.

  PMID: 29142450 RESULT

• 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.

  PMID: 28333034 RESULT

• 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.

  PMID: 30653117 RESULT

• Cakiroglu Y, Tohma YA, Yuceturk A, Karaosmanoglu O, Aslan IO, Kopuk SY, Korun ZEU, Yazicioglu C, Zeyneloglu HB, Tiras B. A novel technique- subendometrial autologous platelet rich plasma injection in patients with unresponsive thin endometrium undergoing frozen-thawed embryo transfer: a prospective cohort study. BMC Pregnancy Childbirth. 2025 Mar 17;25(1):297. doi: 10.1186/s12884-025-07400-x.

  PMID: 40098101 DERIVED

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hulusi Bulent Zeyneloglu, Prof

  Baskent University Departments of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Yigit Cakiroglu, Assoc.Prof.

  Acibadem University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. 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. On the second menstrual cycle after the procedure, the patients will be checked under ultrasound and will be started hormone replacement therapy for embryo transfer.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: September 15, 2020
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)