Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-20 @ 8:27 PM
Study NCT ID:
NCT04665232
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2016-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunomodulatory Effects of Subcutaneous Progesterone in Patients Affected by Autoimmune Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2016-02-25', 'studyFirstSubmitQcDate': '2020-12-06', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy Rate percentage, Implantation Rate percentage, Live Birth Rate percentage', 'timeFrame': '12 mounths', 'description': 'number of pregnancies / 100 embryotransfer, number of implanted embryos/ number of embryos trafsferred, number of live birth'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['autoimmune diseases and infertility', 'luteal supplementation with subcutaneous progesterone', 'Systemic effect of progesterone'], 'conditions': ['Autoimmune Diseases', 'Infertility']}, 'referencesModule': {'references': [{'pmid': '21880274', 'type': 'BACKGROUND', 'citation': 'Paulson RJ. Hormonal induction of endometrial receptivity. Fertil Steril. 2011 Sep;96(3):530-5. doi: 10.1016/j.fertnstert.2011.07.1097.'}, {'pmid': '23806850', 'type': 'BACKGROUND', 'citation': 'de Ziegler D, Sator M, Binelli D, Leuratti C, Cometti B, Bourgain C, Fu YS, Garhofer G. A randomized trial comparing the endometrial effects of daily subcutaneous administration of 25 mg and 50 mg progesterone in aqueous preparation. Fertil Steril. 2013 Sep;100(3):860-6. doi: 10.1016/j.fertnstert.2013.05.029. Epub 2013 Jun 24.'}, {'pmid': '25681857', 'type': 'BACKGROUND', 'citation': 'Practice Committee of the American Society for Reproductive Medicine. Current clinical irrelevance of luteal phase deficiency: a committee opinion. Fertil Steril. 2015 Apr;103(4):e27-32. doi: 10.1016/j.fertnstert.2014.12.128. Epub 2015 Feb 11.'}, {'pmid': '20034417', 'type': 'BACKGROUND', 'citation': 'Fatemi HM. The luteal phase after 3 decades of IVF: what do we know? Reprod Biomed Online. 2009;19 Suppl 4:4331.'}, {'pmid': '16759928', 'type': 'BACKGROUND', 'citation': 'Stavreus-Evers A, Mandelin E, Koistinen R, Aghajanova L, Hovatta O, Seppala M. Glycodelin is present in pinopodes of receptive-phase human endometrium and is associated with down-regulation of progesterone receptor B. Fertil Steril. 2006 Jun;85(6):1803-11. doi: 10.1016/j.fertnstert.2005.12.018.'}, {'pmid': '10632428', 'type': 'BACKGROUND', 'citation': 'Lim KJ, Odukoya OA, Ajjan RA, Li TC, Weetman AP, Cooke ID. The role of T-helper cytokines in human reproduction. Fertil Steril. 2000 Jan;73(1):136-42. doi: 10.1016/s0015-0282(99)00457-4.'}, {'pmid': '11056250', 'type': 'BACKGROUND', 'citation': 'Faas M, Bouman A, Moesa H, Heineman MJ, de Leij L, Schuiling G. The immune response during the luteal phase of the ovarian cycle: a Th2-type response? Fertil Steril. 2000 Nov;74(5):1008-13. doi: 10.1016/s0015-0282(00)01553-3.'}, {'pmid': '18308048', 'type': 'BACKGROUND', 'citation': 'Rier SE. Environmental immune disruption: a comorbidity factor for reproduction? Fertil Steril. 2008 Feb;89(2 Suppl):e103-8. doi: 10.1016/j.fertnstert.2007.12.040.'}], 'seeAlsoLinks': [{'url': 'http://www.rbmonline.com', 'label': 'The luteal phase after 3 decades of IVF: what do we know? HM Fatemi, Vol.19 Suppl. 4, 2009 Reproductive BioMedicine Online'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the immunomodulatory effects of subcutaneous progesterone in patients undergoing IVF by determination of anti-nuclear antibodies (ANA),extractable nuclear antigen antibodies (ENA),anti- neutrophil cytoplasmic antibodies(ANCA),anti-DNA antibodies, anti-cardiolipin antibodies (ACA),Lupus anticoagulant antibodies (LAC) and C3 and C4 fractions of complement on the day of beta hCG dosage and during the eigth week of gestation.', 'detailedDescription': "The aqueous progesterone preparation for s.c. injection is the first systemic progesterone of its kind for the provision of luteal phase support (LPS) in patients undergoing IVF.\n\nThe the high solubility and rapid absorption of the new preparation are enhanced using cyclodextrins that are starch residues with no therapeutic activity and with a particular molecular structure that closely resembles a 'cap'.\n\nOnce absorbed after injection, the progesterone molecule is immediately dissociated from its cyclodextrin 'cap', remaining free in the circulation as if produced endogenously by the ovaries.\n\nIn comparison to progesterone-in-oil preparation, the new aqueous solution administered by s.c.route resulted in a 3 fold higher and more rapid progesterone peak serum concentrations.\n\nThe immunomodulating effects of progesterone are mediated outside of the pelvic cavity, on the peripheral cell of the immune system. For this reason only the injection procedure has this advantage Furthermore, the faster absorption rate and the higher peak serum concentration should increas the systemic immunomodulatory effect of subcutaneous progesterone compared to the vaginal and intramuscular administration"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infertile patients affected by autoimmune diseases undergoing IVF', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile patients affected by autoimmune diseases undergoing IVF\n\nExclusion Criteria:\n\n* infertile patients without autoimmune diseases, fertile patients affected by autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT04665232', 'briefTitle': 'Immunomodulatory Effects of Subcutaneous Progesterone in Patients Affected by Autoimmune Diseases', 'organization': {'class': 'OTHER', 'fullName': 'San Carlo Public Hospital, Potenza, Italy'}, 'officialTitle': 'Immunomodulatory Effects of Subcutaneous Progesterone in Patients Undergoing IVF Affected by Autoimmune Diseases', 'orgStudyIdInfo': {'id': 'San Carlo Public Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients affected by autoimmune diseases', 'description': 'Infertile patients suffering from autoimmune diseases to be subjected to IVF in which the luteal phase has been supplemented with 25 mg /die of aqueous subcutaneous progesterone', 'interventionNames': ['Drug: aqueous subcutaneous progesterone']}], 'interventions': [{'name': 'aqueous subcutaneous progesterone', 'type': 'DRUG', 'description': '25 mg/die of aqueous subcutaneous progesterone from the day of oocytes retrieval for two weeks.', 'armGroupLabels': ['Patients affected by autoimmune diseases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85100', 'city': 'Potenza', 'country': 'Italy', 'facility': 'Assunta Iuliano', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}], 'overallOfficials': [{'name': 'Assunta Iuliano, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Carlo Public Hospital, Potenza, Italy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '30 years', 'ipdSharing': 'YES', 'description': 'We have a register which shows the number of the medical record of the patient', 'accessCriteria': 'Archive of Medically Assisted Procreation of San Carlo Hospital'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Carlo Public Hospital, Potenza, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Assunta Iuliano, MD', 'investigatorAffiliation': 'San Carlo Public Hospital, Potenza, Italy'}}}}