Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-27 @ 8:00 AM
Study NCT ID:
NCT04424160
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2020-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Platelet Rich Plasma on Endometrium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006175', 'term': 'Gynatresia'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2020-06-06', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endometrial thickness during hormone replacement therapy', 'timeFrame': '2-10 months', 'description': 'To measure endometrial thickness assessed by ultrasound during hormone replacement therapy for endometrial preparation in frozen-thawed cycles'}], 'secondaryOutcomes': [{'measure': 'Pregnancy outcomes after frozen-thawed embryo transfer', 'timeFrame': '2-10 months', 'description': 'To assess pregnancy rates by beta-human chorionic gonadotropin and ultrasound after frozen-thawed embryo transfer cycles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asherman Syndrome']}, 'referencesModule': {'references': [{'pmid': '25785127', 'type': 'RESULT', '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.'}, {'pmid': '29142450', 'type': 'RESULT', '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.'}, {'pmid': '28333034', 'type': 'RESULT', '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.'}, {'pmid': '30653117', 'type': 'RESULT', '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.'}, {'pmid': '40098101', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'All infertile women desiring pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Women with a history of Asherman syndrome, but no obvious intrauterine adhesion in the last hysteroscopic procedure;\n* Women who have at least 2 frozen good-quality embryos.\n\nExclusion Criteria:\n\n* Women with any other known cause of implantation failure, such as poor embryo quality, or congenital uterine anomalies, endometrial polyp or fibroid,\n* Previous diagnosis of any malignancy,\n* Anticoagulant use for which plasma infusion is contraindicated,'}, 'identificationModule': {'nctId': 'NCT04424160', 'briefTitle': 'Effects of Platelet Rich Plasma on Endometrium', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Effects of Intrauterine Platelet Rich Plasma (PRP) on Endometrium and Pregnancy Rates in Patients With Suboptimal Endometrium Undergoing Frozen Embryo Transfer', 'orgStudyIdInfo': {'id': 'KA20/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endometrial PRP', 'description': 'Patients in whom endometrial PRP was performed', 'interventionNames': ['Biological: PRP injection in the endometrium']}], 'interventions': [{'name': 'PRP injection in the endometrium', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Endometrial PRP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34460', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Acıbadem Maslak Hospital IVF Unit', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Hulusi Bulent Zeyneloglu, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baskent University Departments of Obstetrics and Gynecology'}, {'name': 'Yigit Cakiroglu, Assoc.Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Acibadem University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baskent University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Bulent Tiras', 'investigatorAffiliation': 'Acibadem University'}}}}