Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-02 @ 6:00 AM
Study NCT ID:
NCT06684951
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2024-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D007246', 'term': 'Infertility'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'khokh7871@gmail.com', 'phone': '9647831475217', 'title': 'Omaima Ismail Khalaf', 'organization': 'AlNahrain university'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'information about adverse event effect performed using questionnaire, regular laboratory testing and the intervention is by using intrauterine infusion of low dose of drug which nearly carry no risk to the patients', 'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity and biochemical marker including TNF-alfa and IL-10', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B', 'description': 'Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group C', 'description': 'patient not receive any treatement', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Level of TNF-alfa,IL-10, for All Participants in Three Study Group at Day of Ova Pickup Compared to That at Day of Embryo Transfer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity and biochemical marker including TNF-alfa and IL-10'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'OG002', 'title': 'Group C', 'description': 'patient not receive any treatement'}], 'classes': [{'title': 'serum level of TNF-alfa at day of ova pickup', 'categories': [{'measurements': [{'value': '43.56', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '41.59', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '40.94', 'spread': '14.4', 'groupId': 'OG002'}]}]}, {'title': 'TNF-alfa day of embryo transfer', 'categories': [{'measurements': [{'value': '30.33', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '38.06', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '42.3', 'spread': '18.7', 'groupId': 'OG002'}]}]}, {'title': 'IL-10 day of pickup', 'categories': [{'measurements': [{'value': '25.26', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '27.08', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '25.57', 'spread': '8.3', 'groupId': 'OG002'}]}]}, {'title': 'IL-10 day of embryo transfer', 'categories': [{'measurements': [{'value': '25.21', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '25.51', 'spread': '12.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at day of ova pickup a blood sample aspirated, and on day of embryo transfer about 3-5 days post ova pickup blood sample taken within ten minute before embryo transfer to asses serum level of TNF-alfa and IL-10 for all participent', 'description': 'All participants in the study had a blood sample taken on the day of ovum retrieval (within 10 minute after ova pickup) for the purpose of measuring the level of interleukin-10 and TNF-alfa in the blood, and a second sample was taken on the day of embryo transfer (ten minute before embryo transfer) to asses both marker,', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ultrasound Parameter (RI,PI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'OG002', 'title': 'Group C', 'description': 'patient not receive any treatement'}], 'classes': [{'title': 'Resistance index day of pickup', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.05', 'groupId': 'OG002'}]}]}, {'title': 'Resistance index day of transfer', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.07', 'groupId': 'OG002'}]}]}, {'title': 'Pulsatile index day of pickup', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '0.79', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Pulsatile index day of transfer', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.78', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 10 minutes after ova pickup, ten minute before embryo transfer using ultrasound device', 'description': 'assessment of sub-endometrial blood flow indicis immediately within 10 minute post ova pickup and second exam within ten minute before embryo transfer day which is within 3-5 days of ova pickup there are no maximum or minimum value for the parameter to be measured and lower value is better these measure was performed by using ultrasound device', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Systole Flow/ Diastole Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'OG002', 'title': 'Group C', 'description': 'patient not receive any treatement'}], 'classes': [{'title': 'systole/ diastole ratio day of pickup', 'categories': [{'measurements': [{'value': '2.05', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2.01', 'spread': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'systole/diastole ratio day of transfer', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.92', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup', 'description': 'ultrasound parameter to asses endometrial receptivity by measuring sub-endometrial flow systole / diastole ratio', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'TNF-alfa/IL-10 Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'OG002', 'title': 'Group C', 'description': 'patient not receive any treatement'}], 'classes': [{'title': 'TNF/IL-10 ratio at day of ova pickup', 'categories': [{'measurements': [{'value': '1.89', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '1.71', 'spread': '0.47', 'groupId': 'OG002'}]}]}, {'title': 'TNF/IL-10 ratio at day of embryo transfer', 'categories': [{'measurements': [{'value': '1.38', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '1.86', 'spread': '1.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup', 'description': 'ratio of serum level of TNA-alfa /IL-10 at time of ova pickup and at day of embryo transfer', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intra Cytoplasmic Sperm Injection Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'OG002', 'title': 'Group C', 'description': 'patient not receive any treatement'}], 'classes': [{'categories': [{'title': 'pregnant women', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': 'non-pregnant women', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days after embryo transfer beta-hCG titer performed to asses pregnancy', 'description': 'Number of patients who get pregnant after ICSI in each study group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A', 'description': 'Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'FG001', 'title': 'Group B', 'description': 'Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'FG002', 'title': 'Group C', 'description': 'patient not receive any treatement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited based on patients whom attended the out patient clinic of the High Institute for Infertility Diagnosis and Assisted reproductive technique/ Al Nahrain university, between October 2022 and January 2024.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A', 'description': 'Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'BG001', 'title': 'Group B', 'description': 'Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup\n\nhCG: observe hCG effect on endometrial receptivity'}, {'id': 'BG002', 'title': 'Group C', 'description': 'patient not receive any treatement'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'age of participants (years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Age < 25', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': '25-34', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': '≥ 35', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'female participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'all participants were infertile female attended out patient clinic for high institute for infertility diagnosis and assisted repr0ductive technique', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Iraq', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'aii patients enrolled in the study collected from high institute for infertility diagnosis and assisted reproductive technique / Al Nahrain university', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index (BMI) Kg/m^2', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Normal BMI', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'over weight', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'obese', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of infertility (primary/secondary)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'title': 'primary', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'secondary', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cause of infertility', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'title': 'male factor', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}, {'title': 'female factor', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Combined', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Unexplained', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of infertility', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'categories': [{'title': '< 5 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': '5 - 9 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': '≥ 10 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-16', 'size': 2114043, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-25T17:35', 'hasProtocol': True}, {'date': '2024-10-16', 'size': 862129, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-19T10:43', 'hasProtocol': False}, {'date': '2024-10-16', 'size': 543656, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-25T17:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2024-08-20', 'resultsFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-11-10', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-04-15', 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Level of TNF-alfa,IL-10, for All Participants in Three Study Group at Day of Ova Pickup Compared to That at Day of Embryo Transfer', 'timeFrame': 'at day of ova pickup a blood sample aspirated, and on day of embryo transfer about 3-5 days post ova pickup blood sample taken within ten minute before embryo transfer to asses serum level of TNF-alfa and IL-10 for all participent', 'description': 'All participants in the study had a blood sample taken on the day of ovum retrieval (within 10 minute after ova pickup) for the purpose of measuring the level of interleukin-10 and TNF-alfa in the blood, and a second sample was taken on the day of embryo transfer (ten minute before embryo transfer) to asses both marker,'}, {'measure': 'Ultrasound Parameter (RI,PI)', 'timeFrame': 'Within 10 minutes after ova pickup, ten minute before embryo transfer using ultrasound device', 'description': 'assessment of sub-endometrial blood flow indicis immediately within 10 minute post ova pickup and second exam within ten minute before embryo transfer day which is within 3-5 days of ova pickup there are no maximum or minimum value for the parameter to be measured and lower value is better these measure was performed by using ultrasound device'}, {'measure': 'Systole Flow/ Diastole Flow', 'timeFrame': 'within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup', 'description': 'ultrasound parameter to asses endometrial receptivity by measuring sub-endometrial flow systole / diastole ratio'}, {'measure': 'TNF-alfa/IL-10 Ratio', 'timeFrame': 'within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup', 'description': 'ratio of serum level of TNA-alfa /IL-10 at time of ova pickup and at day of embryo transfer'}], 'secondaryOutcomes': [{'measure': 'Intra Cytoplasmic Sperm Injection Outcome', 'timeFrame': '14 days after embryo transfer beta-hCG titer performed to asses pregnancy', 'description': 'Number of patients who get pregnant after ICSI in each study group'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Implantation', 'Infertility', 'Human Chorionic Gonadotropin'], 'conditions': ['Female Infertility']}, 'descriptionModule': {'briefSummary': 'a number of infertile women who were prepared for ICSI and immediately post ova pick up intrauterine flushing with human chorionic gonadotropin was done to study the effect of this drug on ICSI outcome and ultrasound parameter.', 'detailedDescription': 'Ninety infertile women included. Written informed consent was obtained before being included in the study. Three groups of patients according to type of intervention. Assessment of plasma hormone level was done for all. The quantification of serum TNF and IL-10 levels was conducted through the application of the enzyme-linked immunosorbent assay (ELISA) methodology at a privately-owned laboratory.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'intertile female age (18-40), no history of endocrinological disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient\\'s consent to participate in the research study is crucial for data collection and analysis.\n2. Each pair of individuals undergoing IVF/ICSI procedures typically possess grade 1 (G1) embryos during the embryo transfer process.\n3. The age range of the female participants varied from 18 to 40 years.\n4. Infertility arising from female factors, including issues like blocked fallopian tubes, lack of ovulation, and unexplained fertility challenges, was examined.\n5. Male-related factors contributing to infertility were also taken into consideration.\n6. The procedure involved the transfer of grade one embryos during a fresh cycle.\n\nExclusion Criteria:\n\nEndometrioses, whether clinically suspected or discovered during laparoscopy, are of interest.\n\n2\\. Instances of congenital abnormalities in the reproductive system are being examined.\n\n3\\. Individuals above the age of forty are under consideration. 4. Individuals who do not possess G1 embryos are also included. 5. Patients with chronic systemic conditions (such as diabetes, hematologic disorders, hypertension, autoimmune disorders of the connective tissue, asthma, thyroid disorders) are a part of the study.\n\n6\\. The presence of empty follicles is noted in stimulated cycles where no oocytes were obtained during the aspiration procedure.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06684951', 'briefTitle': 'Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Al-Nahrain University'}, 'officialTitle': 'Study the Effects of Intrauterine Flushing With Low Dose Human Chorionic Gonadotropin on Ultrasound Parameter and Immunological Marker of Endometrial Receptivity of Infertile Female Undergoing ICSI Cycle', 'orgStudyIdInfo': {'id': '0701-PF-2022O10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup', 'interventionNames': ['Drug: hCG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup', 'interventionNames': ['Drug: hCG']}, {'type': 'NO_INTERVENTION', 'label': 'group C', 'description': 'patient not receive any treatement'}], 'interventions': [{'name': 'hCG', 'type': 'DRUG', 'description': 'observe hCG effect on endometrial receptivity', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baghdad', 'country': 'Iraq', 'facility': 'High Institute for Infertility Diagnosis and Assisted Reproductive Technology', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'Manal T Al-Obaidi, phD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'High Institute for Infertility Diagnosis and Reproductive Technique'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Omayma Ismail Khalaf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Omayma Ismail Khalaf', 'investigatorAffiliation': 'Al-Nahrain University'}}}}