Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-05 @ 10:31 PM
Study NCT ID:
NCT02757469
Status:
UNKNOWN
Last Update Posted:
2016-05-02
First Post:
2016-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}, {'id': 'D008594', 'term': 'Menopause, Premature'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C035144', 'term': 'drospirenone'}, {'id': 'C534342', 'term': 'drospirenone and ethinyl estradiol combination'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-27', 'studyFirstSubmitDate': '2016-04-24', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'live birth', 'timeFrame': '3 years', 'description': 'The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).'}], 'secondaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '3 years', 'description': 'The ratio of the number of conceptions (CONCEPTION) including LIVE BIRTH; STILLBIRTH; and fetal losses, to the mean number of females of reproductive age in a population during a set time period.'}, {'measure': 'multiple pregnancy', 'timeFrame': '3 years', 'description': 'The condition of carrying two or more FETUSES.'}, {'measure': 'miscarriage', 'timeFrame': '3 years', 'description': 'Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Primary Ovarian Insufficiency', 'Menopause, Premature']}, 'referencesModule': {'references': [{'pmid': '3080719', 'type': 'BACKGROUND', 'citation': 'Alper MM, Jolly EE, Garner PR. Pregnancies after premature ovarian failure. Obstet Gynecol. 1986 Mar;67(3 Suppl):59S-62S. doi: 10.1097/00006250-198603001-00018.'}, {'pmid': '24341612', 'type': 'RESULT', 'citation': 'Ben-Nagi J, Panay N. Premature ovarian insufficiency: how to improve reproductive outcome? Climacteric. 2014 Jun;17(3):242-6. doi: 10.3109/13697137.2013.860115. Epub 2013 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'Premature ovarian insufficiency (POI) is a life-changing condition that affects women in their reproductive age. There is a lack of reports which focus on how to improve the reproductive outcome of these women who wish to conceive spontaneously or use assisted conception with their own oocytes. However, one could surmise that it is important to lower gonadotropin levels into the physiological range before embarking on any treatment, even if natural conception is the only choice for the woman/couple.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premature ovarian failure\n* normal anatomy\n* normal secondary sexual characteristics\n* essential or idiopathic\n\nExclusion Criteria:\n\n* chromosomal disorder\n* iatrogenic injury\n* autoimmune diseases\n* infection\n* genetic diseases'}, 'identificationModule': {'nctId': 'NCT02757469', 'briefTitle': 'Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure', 'organization': {'class': 'OTHER', 'fullName': 'Navy General Hospital, Beijing'}, 'officialTitle': 'Drospirenone and Ethinyl Estradiol Combinations (Yasmin) as Infertility Treatments for Premature Ovarian Failure: a Perspective Follow-up Study.', 'orgStudyIdInfo': {'id': 'OCPOF-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yasmin', 'description': 'Pregnancies will occur while the women are taking oral contraceptives (Yasmin). The possible role of exogenous estrogens in sensitizing the granulosa cells to the effect of follicle-stimulating hormone and thereby inducing ovulation and conception in some women with premature ovarian failure is examined.', 'interventionNames': ['Drug: Drospirenone and ethinyl estradiol combination (Yasmin)']}], 'interventions': [{'name': 'Drospirenone and ethinyl estradiol combination (Yasmin)', 'type': 'DRUG', 'description': 'Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)', 'armGroupLabels': ['Yasmin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100048', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yunhai Chuai, Dr', 'role': 'CONTACT', 'email': 'wangyh85@foxmail.com', 'phone': '+86-18810892004'}, {'name': 'Wei Shang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lei Chen, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yunhai Chuai, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mingming Shu, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ming Zhou, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mengnan Chen, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Huiming Han, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Navy General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yunhai Chuai, Dr', 'role': 'CONTACT', 'email': 'wangyh85@foxmail.com', 'phone': '+86-18810892004'}], 'overallOfficials': [{'name': 'Wei Shang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Navy General Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navy General Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Obstetrics and Gynecology, Navy General Hospital, Beijing', 'investigatorFullName': 'Yunhai Chuai', 'investigatorAffiliation': 'Navy General Hospital, Beijing'}}}}