Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-03-29 @ 1:55 AM
Study NCT ID:
NCT04247204
Status:
UNKNOWN
Last Update Posted:
2020-01-29
First Post:
2020-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen Embryo Transfer Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-10-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2020-01-24', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascularization index of the endometrial region', 'timeFrame': 'Day 15 to 18 of the frozen embryo transfer cycle', 'description': 'Vascularization index of the endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis.'}], 'secondaryOutcomes': [{'measure': 'Flow index of the endometrial region', 'timeFrame': 'Day 15 to 18 of the frozen embryo transfer cycle', 'description': 'Flow index of the endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis'}, {'measure': 'Vascularization flow index of the endometrial region', 'timeFrame': 'Day 15 to 18 of the frozen embryo transfer cycle', 'description': 'Vascularization flow index of the endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis'}, {'measure': 'Vascularization index of the sub-endometrial region', 'timeFrame': 'Day 15 to 18 of the frozen embryo transfer cycle', 'description': 'Vascularization flow index of the sub-endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis'}, {'measure': 'Flow index of the sub-endometrial region', 'timeFrame': 'Day 15 to 18 of the frozen embryo transfer cycle', 'description': 'Flow index of the sub-endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis'}, {'measure': 'Vascularization flow index of the sub-endometrial region', 'timeFrame': 'Day 15 to 18 of the frozen embryo transfer cycle', 'description': 'Vascularization flow index of the sub-endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frozen Embryo Transfer']}, 'referencesModule': {'references': [{'pmid': '24447958', 'type': 'BACKGROUND', 'citation': 'Nandi A, Martins WP, Jayaprakasan K, Clewes JS, Campbell BK, Raine-Fenning NJ. Assessment of endometrial and subendometrial blood flow in women undergoing frozen embryo transfer cycles. Reprod Biomed Online. 2014 Mar;28(3):343-51. doi: 10.1016/j.rbmo.2013.11.004. Epub 2013 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'A good quality embryo and receptive endometrium are important aspects in achieving optimal outcomes in assisted reproductive treatment (ART). Endometrial thickness is an important marker of uterine receptivity. A thin endometrium defined by an endometrial thickness ≤7mm was reported as a poor factor associated with significantly lower implantation and pregnancy rates as well as a higher risk of miscarriage.\n\nNowadays, platelet-rich plasma (PRP) intrauterine infusion is a promising approach for the treatment of refractory thin endometrium in patients undergoing frozen-thawed embryo transfer. This is based on its ability to stimulate proliferation and angiogenesis with a large number of growth factors and cytokines i.e. the endometrium becomes thicker, with higher vascularity. PRP is easily prepared from an autologous blood sample that eliminates the risk of immunological reactions and transmission infections at low cost.\n\nEndometrial blood flow is another important marker reflective of uterine receptivity. Although publications are increasing concerning the efficacy of PRP intrauterine infusion on endometrial expansion and proliferation in frozen-thawed embryo transfer cycles, yet its angiogenetic effects have not been evaluated so far in either thin endometrium or normal endometrium thickness.\n\nOur study aims to evaluate endometrial and sub-endometrial vasculature patterns before and after PRP infusion in frozen-thawed embryo transfer cycles with normal endometrium thickness.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subfertile women undergoing frozen-thawed embryo transfer with at least previously failed one ICSI cycle.\n* Age between 20-35 years.\n* Women with endometrium thickness between 8-14 mm on D15 of the frozen embryo transfer cycle\n\nExclusion Criteria:\n\n* Women with a thin endometrium (≤ 7 mm) on day 15 of the cycle.\n* Women with known hematological or immunological disorders\n* Women with uncontrolled endocrine or other medical conditions, such as hyperprolactinemia or thyroid diseases.\n* Women with uterine abnormalities e.g. Asherman syndrome, myomas, uterine septum, bicornuate uterus.\n* Women who refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT04247204', 'briefTitle': 'Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen Embryo Transfer Cycles', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': '3D Power Doppler Ultrasound Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen-thawed Embryo Transfer Cycles: a Pilot Study.', 'orgStudyIdInfo': {'id': 'R.20.01.711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet-rich plasma (PRP) intrauterine infusion', 'interventionNames': ['Biological: Platelet-rich plasma intrauterine infusion']}], 'interventions': [{'name': 'Platelet-rich plasma intrauterine infusion', 'type': 'BIOLOGICAL', 'description': 'For all women, basic transvaginal sonography will be done in the 2nd day of frozen embryo transfer (FET) cycle and they will receive standard hormone replacement therapy (HRT) in the form of estradiol valerate tablets (white tablets of Cyclo-Progynova; Bayer Schering Pharma AG, Germany) at a dose of 4mg for 7 days then 6mg for 6 days. Endometrial assessment will be done on day 15 of FET cycle. Those with endometrial thickness between 8-14 mm will be evaluated for endometrial and sub-endometrial vasculature pattern by 3D power Doppler analysis. Then 1 ml of PRP (prepared from autologous blood) will be infused in the uterine cavity and vaginal progesterone 400 mg twice daily will be prescribed for 3 days. Subsequently, D3 embryos will be transferred. Endometrial, sub-endometrial and uterine arterial vascularity pattern will be re-evaluated on the day of ET. Both estradiol valerate tablets and vaginal progesterone will be continued up to 12th week of gestation in case of pregnancy.', 'armGroupLabels': ['Platelet-rich plasma (PRP) intrauterine infusion']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hatem Abu Hashim, MD. FRCOG.PhD', 'role': 'CONTACT', 'email': 'hatem_ah@hotmail.com', 'phone': '+20502300002'}], 'overallOfficials': [{'name': 'Hatem Abu Hashim, MD. FRCOG. PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine, Mansoura University'}, {'name': 'Mohamed Taman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hatem AbuHashim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hatem AbuHashim', 'investigatorAffiliation': 'Mansoura University'}}}}