Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
Study NCT ID:
NCT03904368
Status:
UNKNOWN
Last Update Posted:
2019-04-05
First Post:
2019-03-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Value of Myomectomy in Women With Intramural Myoma Before IVF.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'D004624', 'term': 'Embryo Transfer'}], 'ancestors': [{'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2019-03-31', 'studyFirstSubmitQcDate': '2019-04-03', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '4 weeks after embryo transfer', 'description': 'appearance of one or more intrauterine gestational sac by transvaginal ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibroid Uterus', 'IVF']}, 'descriptionModule': {'briefSummary': 'Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),\n\n, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.', 'detailedDescription': 'Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention .The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),\n\n, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • age younger than 40 years\n\n * FSH) less than 10 IU/L\n * serum prolactin level normal\n * uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography\n\nExclusion Criteria:\n\n* abnormal endocrine function (e.g. abnormal thyroid or adrenal function)\n* ovarian cysts,\n* hydrosalpinx\n* endometrial polyps\n* male partner with azoospermia\n* ICSI performed for preimplantation genetic diagnosis.'}, 'identificationModule': {'nctId': 'NCT03904368', 'briefTitle': 'The Value of Myomectomy in Women With Intramural Myoma Before IVF.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Value of Myomectomy in Women With Intramural Myoma Before IVF. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Myomectomy group', 'description': 'women with intramural myoma not reaching endometrial cavity will undergo open myomectomy followed by ovarian stimulation for in vitro fertilization 6 months after the operation', 'interventionNames': ['Procedure: Open myomectomy', 'Drug: Gonadotropins', 'Drug: Human chorionic gonadotropin', 'Procedure: Ovum pick up', 'Procedure: Embryo transfer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative group', 'description': 'women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization', 'interventionNames': ['Drug: Gonadotropins', 'Drug: Human chorionic gonadotropin', 'Procedure: Ovum pick up', 'Procedure: Embryo transfer']}], 'interventions': [{'name': 'Open myomectomy', 'type': 'PROCEDURE', 'description': 'laparotomy then enucleation of the myoma followed by closure of the myometrial cavity', 'armGroupLabels': ['Myomectomy group']}, {'name': 'Gonadotropins', 'type': 'DRUG', 'otherNames': ['Controlled Ovarian stimulation'], 'description': 'Gonadotropin stimulation of follicular growth', 'armGroupLabels': ['Conservative group', 'Myomectomy group']}, {'name': 'Human chorionic gonadotropin', 'type': 'DRUG', 'otherNames': ['Ovulation triggering'], 'description': 'HCG triggering of ovulation', 'armGroupLabels': ['Conservative group', 'Myomectomy group']}, {'name': 'Ovum pick up', 'type': 'PROCEDURE', 'description': '34 to 36 hours after HCG triggering', 'armGroupLabels': ['Conservative group', 'Myomectomy group']}, {'name': 'Embryo transfer', 'type': 'PROCEDURE', 'description': 'Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval', 'armGroupLabels': ['Conservative group', 'Myomectomy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Maged, MD', 'role': 'CONTACT', 'email': 'prof.ahmedmaged@gmail.com', 'phone': '+201005227404'}], 'overallOfficials': [{'name': 'Ahmed Maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ahmed M Maged, MD', 'investigatorAffiliation': 'Cairo University'}}}}