Clinical trial NCT04424160: Effects of Platelet Rich Plasma on Endometrium
Official title: Effects of Intrauterine Platelet Rich Plasma (PRP) on Endometrium and Pregnancy Rates in Patients With Suboptimal Endometrium Undergoing Frozen Embryo Transfer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asherman Syndrome
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Baskent University
First posted: 2020-06-09
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Endometrial thickness during hormone replacement therapy
timeFrame: 2-10 months
Secondary outcomes:
measure: Pregnancy outcomes after frozen-thawed embryo transfer
timeFrame: 2-10 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Maslak Hospital IVF Unit
Study officials:
affiliation: Baskent University Departments of Obstetrics and Gynecology
name: Hulusi Bulent Zeyneloglu, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Acibadem University
name: Yigit Cakiroglu, Assoc.Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
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: 10.4103/jhrs.JHRS_28_17.
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.
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.0000000000014062.