Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
Study NCT ID:
NCT05152667
Status:
UNKNOWN
Last Update Posted:
2021-12-10
First Post:
2021-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ambispective Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062788', 'term': 'Adenomyosis'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 354}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-27', 'studyFirstSubmitDate': '2021-08-13', 'studyFirstSubmitQcDate': '2021-11-27', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ongoing pregnancy', 'timeFrame': 'up to 13 weeks gestation', 'description': '\\- Recording the following for the two arms of the study: Presence of intrauterine gestational sac at 12 weeks Presence of fetal heart pulsation at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Occurance of abortion or ectopic', 'timeFrame': 'up to 13 weeks gestation', 'description': 'Recording the following for the two arms of the study:\n\nOccurance of abortion in the 1st trimester Appearance of ectopic pregnancy diagnosis Two serum β-HCG levels in 48hrs interval'}, {'measure': 'Recording the baseline characteristics of the study participants', 'timeFrame': 'Before study intervention', 'description': 'age'}, {'measure': 'Recording the baseline characteristics of the study participants', 'timeFrame': 'Before study intervention', 'description': 'BMI in kg/m\\^2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adenomyosis', 'IVF']}, 'descriptionModule': {'briefSummary': "The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms", 'detailedDescription': 'The study participants\' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms:\n\nArm 1: Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI Arm 2: Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI Primary and secondary key measurements will be used in the study.\n\nThe primary measures will include:\n\n* Presence of intrauterine gestational sac at 12 weeks\n* Presence of fetal heart pulsation at 12 weeks\n\nThe secondary key measures will include:\n\n* Occurance of abortion in the 1st trimester\n* Appearance of ectopic pregnancy diagnosis by:\n\nUltrasound Serum β-HCG level Symptoms of pain and bleeding\n\n* Two serum β-HCG levels in 48hrs interval to emphasis biochemical pregnancy\n* Recording the the baseline characteristics of the study participants'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '42 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include women with adenomyosis, proceeding with the ICSI and pretreated with either:\n\n1. levonorgestrel-releasing intrauterine device (LNG-IUS)\n2. Oral progestin "Dienogest"', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed using both the transvaginal ultrasound study (TVS) and MRI criteria\n\n * Main criteria for sonographic and MRI diagnosis of adenomyosis are:\n\n The appearance of asymmetrical thickening of the myometrium Irregular cystic areas within the myometrium Linear striations radiating out from the myometrium\n2. Patients ≤42 years old at the time of starting ICSI cycle\n3. Cryopreserved embryo transfer cycles\n4. The presence of at least one good cryopreserved day 3 embryo.\n\nExclusion Criteria:\n\n1. Transfer of a poor-quality embryo (grades 3 or 4)\n2. History of myomectomy\n3. Pelvic ultrasound that showed the presence of uterine fibroids, a hydrosalpinx or endometrial polyps (all known causes of implantation failure).'}, 'identificationModule': {'nctId': 'NCT05152667', 'briefTitle': 'Ambispective Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin', 'organization': {'class': 'OTHER', 'fullName': 'Wael Elbanna Clinic'}, 'officialTitle': 'Ambispective Comparative Cohort Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin on ICSI and Vitrified-Warmed Embryo Transfer Outcomes in Women With Adenomyosis', 'orgStudyIdInfo': {'id': 'Elbanna_001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1', 'description': 'Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI', 'interventionNames': ['Device: levonorgestrel-releasing intrauterine device (LNG-IUS)']}, {'label': 'Arm 2', 'description': 'Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI'}], 'interventions': [{'name': 'levonorgestrel-releasing intrauterine device (LNG-IUS)', 'type': 'DEVICE', 'otherNames': ['oral progestin "Dienogest"'], 'description': 'Intervention is administered proceeding the ICSI', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'wael Elbanna, consultant', 'role': 'CONTACT', 'email': 'waelelbanna@drwaelelbanna.com', 'phone': '01227760402'}, {'name': 'manal elhinnawi, specialist', 'role': 'CONTACT', 'phone': '01007970546'}], 'facility': 'Wael Elbanna Clinic', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Wael Saad Saad El Banna El Banna, MD', 'role': 'CONTACT', 'email': 'dr.wael.ss.elbanna@gmail.com', 'phone': '+2 01227760402'}, {'name': 'Eslam Fathy Fathy, M.Sc.', 'role': 'CONTACT', 'email': 'eslam.f486@gmail.com', 'phone': '01092586140'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wael Elbanna Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Centre, Egypt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Managing director for Wael Elbanna Clinic', 'investigatorFullName': 'Wael Elbanna', 'investigatorAffiliation': 'Wael Elbanna Clinic'}}}}