Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00064935
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endometrial Biopsy in Infertile Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 880}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-05', 'completionDateStruct': {'date': '2002-02'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2003-07-15', 'studyFirstSubmitQcDate': '2003-07-15', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Endometrium', 'Luteal phase', 'Endometrial biopsy'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'When a woman becomes pregnant, the fertilized egg attaches itself to the lining of the uterus (endometrium). The endometrium is constantly changing throughout a woman\'s menstrual cycle in response to the female hormones estrogen and progesterone. The endometrium must have certain characteristics (be at a specific phase in its cycle) in order for the fertilized egg to successfully attach. Infertility may be caused by an "out of phase" endometrium (i.e., the endometrium doesn\'t have the right characteristics when the fertilized egg reaches it). The purpose of this study is to evaluate whether the endometrial biopsy is useful in predicting the potential for becoming pregnant and bearing a child.', 'detailedDescription': 'This study will evaluate the utility of the endometrial biopsy as a tool for the routine evaluation of the luteal phase of women presenting for infertility evaluation. The study will establish whether the mid-luteal or late-luteal phase is the most appropriate time to perform an endometrial biopsy. The study will be conducted through the multi-center Reproductive Medicine Network.\n\nWomen with a history of infertility will be age matched to fertile women (controls). Women will be randomized either to the mid-luteal phase (7 to 8 days post-ovulation) endometrial biopsy group or to the late-luteal phase (12 to 13 days post-ovulation) endometrial biopsy group. Endometrial specimens will be evaluated histologically by a "blinded" pathologist.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Fertile Patients (controls)\n\n* No history of involuntary primary or secondary infertility\n* Willingness to discontinue hormonal contraceptives for 1 month prior to and through the duration of the study\n* At least 1 child delivered within 24 months prior to study entry\n* Most recent pregnancy resulting in a live birth (no interim spontaneous abortions)\n* Tubal ligation within 24 months of study entry is acceptable if all other criteria are met\n\nInclusion Criteria for Infertile Patients\n\n* History of primary or secondary infertility for a period of at least 12 months\n* No hormonal treatments in the month preceding study entry\n* No history of tubal ligation'}, 'identificationModule': {'nctId': 'NCT00064935', 'briefTitle': 'Endometrial Biopsy in Infertile Patients', 'organization': {'class': 'NIH', 'fullName': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, 'officialTitle': 'Utility of the Endometrial Biopsy in the Evaluation of the Luteal Phase', 'orgStudyIdInfo': {'id': 'U01HD038997', 'link': 'https://reporter.nih.gov/quickSearch/U01HD038997', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U01HD038997', 'link': 'https://reporter.nih.gov/quickSearch/U01HD038997', 'type': 'NIH'}, {'id': 'NICHD-0803'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Endometrial biopsy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University of Medicine and Dentistry, NJ', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania State University', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Evan Myers, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Medical Center and Duke Clinical Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}}}}