Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-31 @ 7:04 AM
Study NCT ID:
NCT04169451
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2019-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IUI With Letrozole Versus in Natural Cycle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 982}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2019-11-17', 'studyFirstSubmitQcDate': '2019-11-17', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'live birth rate', 'timeFrame': '14 months', 'description': 'Primary outcome is live birth resulting from conception within 4 months after randomization.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrauterine Insemination', 'Unexplained Infertility']}, 'descriptionModule': {'briefSummary': 'Rationale Intrauterine insemination (IUI) is the treatment of first choice for couples with unexplained and mild male factor infertility in many countries, but it is controversial whether ovarian stimulation improves fertility outcomes. In recent retrospectively collected data, we found that in couples with unexplained and mild male factor infertility undergoing IUI, ovarian stimulation with letrozole increased live birth rate as compared to natural cycle IUI without substantially increasing the multiple pregnancy rate. We therefore intend to perform a randomized clinical trial (RCT) on the subject in five reproductive medical centers in different cities in China.\n\nObjective To test the hypothesis that in couples with unexplained or mild male factor infertility scheduled for an IUI program ovarian stimulation with letrozole increases the live birth rate as compared to natural cycle treatment.\n\nStudy design Multicenter randomized controlled trial.\n\nStudy population Women diagnosed with unexplained or mild male factor infertility scheduled for treatment with IUI.\n\nIntervention Women will be randomized for ovarian stimulation with letrozole or to natural cycle IUI. In the group allocated to ovarian stimulation, women will receive oral tablets letrozole 5 mg daily from cycle day 3 for 5 days. We will treat the couples for 3 cycles, with a time horizon of 4 months.\n\nMain study parameters/endpoints Primary outcome is live birth resulting from conception within 4 months after randomization. Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy complications, time to pregnancy leading to live birth.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness The strategies compared are already broadly applied in current practice. No additional risks are expected. There is no benefit for participants, but the results may benefit future infertile couples.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\nIn order to be eligible to participate in this study, a participating couple must meet all of the following criteria:\n\n* Being diagnosed with unexplained or mild male infertility\n* At least one sided tubal patency, established according to local protocol\n* Normal or mild impairment of semen quality defined as total motile sperm count (TMSC) no less than 5million, based on at least one recent semen analysis\n\nExclusion criteria\n\nA potential participant who meets any of the following criteria will be excluded from study participation:\n\n* Woman with double sided tubal pathology\n* Women with irregular cycles, PCOS or other endocrine disorders\n* Man with impaired semen quality: total motile sperm count (TMSC) less than 5million'}, 'identificationModule': {'nctId': 'NCT04169451', 'briefTitle': 'IUI With Letrozole Versus in Natural Cycle', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Intrauterine Insemination With Letrozole Versus Intrauterine Insemination in Natural Cycle. A Muticenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IUI with/without stimulation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'letrozole group', 'description': 'Women will be given IUI treatment with ovarian stimulation with letrozole 5mg/day starting from day 3 of menstrual cycle for 5 days.', 'interventionNames': ['Drug: Letrozole']}, {'type': 'NO_INTERVENTION', 'label': 'natural cycle group', 'description': 'Women will be given IUI treatment without ovarian stimulation.'}], 'interventions': [{'name': 'Letrozole', 'type': 'DRUG', 'description': 'Women will be randomized to the group with ovarian stimulation with letrozole or the group without stimulation.', 'armGroupLabels': ['letrozole group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuo Huang, Dr', 'role': 'CONTACT'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shuo Huang', 'role': 'CONTACT', 'email': 'homelyleaf@aliyun.com', 'phone': '86-13601203410'}], 'overallOfficials': [{'name': 'Jie Qiao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking Unversity Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The 1st Affiliated Hospital of Anhui Medical University', 'class': 'UNKNOWN'}, {'name': 'The 2nd Affiliated Hospital of Hebei Medical University', 'class': 'UNKNOWN'}, {'name': 'Tianjin Central Hospitalof Gynecology Obstetrics', 'class': 'UNKNOWN'}, {'name': "Yunnan1stpeople's hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jie Qiao', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}