Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT01424618
Status:
UNKNOWN
Last Update Posted:
2011-08-29
First Post:
2011-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'C061018', 'term': 'ganirelix'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'lastUpdateSubmitDate': '2011-08-25', 'studyFirstSubmitDate': '2011-08-25', 'studyFirstSubmitQcDate': '2011-08-25', 'lastUpdatePostDateStruct': {'date': '2011-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endometrial thickness measured by ultrasound', 'timeFrame': '2-4 weeks', 'description': 'In office ultrasound to measure thickness of endometrial lining.'}], 'secondaryOutcomes': [{'measure': 'endometrial biopsy', 'timeFrame': '3-6 weeks', 'description': 'In office aspiration of endometrial cells will be examined microscopically to determine if they are at an appropriate stage for implantation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Donor eggs', 'Donor oocytes', 'Pregnancy', 'Embryo Implantation', 'Infertility', 'IVF'], 'conditions': ['Implantation, Embryo']}, 'descriptionModule': {'briefSummary': 'This study compares two different methods to prepare the uterine lining of recipients for implantation in cycles using donor eggs. The study method requires less time than the standard method.\n\nIt is hypothesized that both methods would be suitable for use in egg donor cycles.', 'detailedDescription': "Currently a combination of medications is used to prepare the uterine lining of recipients for implantation in egg donor cycles. The protocol used most commonly is as follows: Initially the individual's own pituitary-ovarian system is suppressed using a GnRH agonist so there are not conflicting signals sent to the uterus. This is followed by hormonal medication identical to what is secreted by the ovaries to prepare the uterine lining for subsequent embryo transfer in donor egg cycles.This preparation typically takes a minimum of four weeks.\n\nThis study will compare a different medication, a GnRh antagonist (which is commonly used in IVF) to suppress an individual's system during the preparation of the uterine lining. This protocol would generally take only two weeks to prepare the uterine lining."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* recipients awaiting egg donation\n* some ovarian function\n* normal endometrial cavity\n\nExclusion Criteria:\n\n* submucosal myoma\n* myoma(s) greater than 4 centimeters\n* endometrial polyp\n* DES exposure\n* documented recalcitrant thin endometrium ( \\<7 mm)\n* untreated vulvovaginitis\n* active pelvic infection\n* endometrial cancer or suspected/known hormonally sensitive cancers\n* breast cancer\n* thromboembolic disease\n* cerebrovascular or coronary heart disease\n* diabetes mellitus\n* hepatic tumors or active liver disease\n* severe hypertension\n* headaches with neurologic disease\n* cholestatic disease\n* heavy smoking over age 35'}, 'identificationModule': {'nctId': 'NCT01424618', 'briefTitle': 'A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs', 'organization': {'class': 'INDIV', 'fullName': 'Kelly, Maureen, M.D.'}, 'officialTitle': 'A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles', 'orgStudyIdInfo': {'id': '39604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GnRh agonist', 'description': 'This arm will use a GnRH agonist to suppress pituitary-ovarian function', 'interventionNames': ['Drug: Leuprolide']}, {'type': 'EXPERIMENTAL', 'label': 'GnRH antagonist', 'description': 'A GnRH antagonist will be used to suppress pituitary-ovarian function', 'interventionNames': ['Drug: Ganirelix']}], 'interventions': [{'name': 'Leuprolide', 'type': 'DRUG', 'otherNames': ['Lupron'], 'description': 'leuprolide 10 units daily, decreased to 5 units daily once suppression achieved for a total of approximately 4 weeks. Once suppression achieved, estradiol and progesterone administered to mature uterine lining.', 'armGroupLabels': ['GnRh agonist']}, {'name': 'Ganirelix', 'type': 'DRUG', 'otherNames': ['Antagon'], 'description': 'Ganirelix 250 mcg daily will be used to suppress pituitary-ovarian function and is administered concurrently with estradiol and progesterone for approximately two weeks.', 'armGroupLabels': ['GnRH antagonist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dana Tillotson, BSN', 'role': 'CONTACT', 'email': 'dtillotson@reproductivemedicinepa.com', 'phone': '215-829-8110'}, {'name': 'Maureen Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Society Hill Reproductive Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Dana Tillotson, BSN', 'role': 'CONTACT', 'email': 'dtillotson@reproductivemedicinepa.com', 'phone': '215-829-8110'}], 'overallOfficials': [{'name': 'Maureen Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Society Hill Reproductive Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kelly, Maureen, M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Maureen Kelly, M.D.', 'investigatorAffiliation': 'Kelly, Maureen, M.D.'}}}}