Effects of Platelet Rich Plasma on Endometrium

NCT ID: NCT04424160

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-04-19

Brief Summary

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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

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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.

Conditions

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Asherman Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endometrial PRP

Patients in whom endometrial PRP was performed

Group Type EXPERIMENTAL

PRP injection in the endometrium

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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,
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role collaborator

Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Bulent Tiras

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hulusi Bulent Zeyneloglu, Prof

Role: PRINCIPAL_INVESTIGATOR

Baskent University Departments of Obstetrics and Gynecology

Yigit Cakiroglu, Assoc.Prof.

Role: STUDY_DIRECTOR

Acibadem University

Locations

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Acıbadem Maslak Hospital IVF Unit

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 25785127 (View on PubMed)

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.

Reference Type RESULT
PMID: 29142450 (View on PubMed)

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.

Reference Type RESULT
PMID: 28333034 (View on PubMed)

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.

Reference Type RESULT
PMID: 30653117 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40098101 (View on PubMed)

Other Identifiers

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KA20/23

Identifier Type: -

Identifier Source: org_study_id

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