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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04424160
Other study ID # KA20/23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date April 19, 2021

Study information

Verified date April 2021
Source Acibadem University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date April 19, 2021
Est. primary completion date April 19, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Acibadem Maslak Hospital IVF Unit Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Acibadem University Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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.000000 — View Citation

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: 1 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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