Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05823194
Status:
UNKNOWN
Last Update Posted:
2023-04-21
First Post:
2023-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "The study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-09', 'studyFirstSubmitDate': '2023-03-18', 'studyFirstSubmitQcDate': '2023-04-09', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of pregnancy of patients received FSS', 'timeFrame': 'In 12 years after FSS', 'description': 'Incidence and rate of patients getting pregnant after FSS'}, {'measure': 'Rate of pregnancy after FSS of patients seeking fertility by applying to IVF clinics', 'timeFrame': 'In 12 years after FSS', 'description': 'Rate of patients referring to IVF clinic after FSS'}], 'secondaryOutcomes': [{'measure': 'Satisfaction assesed by WHO-QoL Bref and decision-regret scale after FSS', 'timeFrame': '12 years', 'description': "% of patients' satisfaction via Quality of life after the surgery, and decision-regret analysis regarding to fertility sparing by the validated questionnaires"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fertility sparing', 'gynecologic malignancy', 'quality of life', 'infertility'], 'conditions': ['Fertility Disorders', 'Gynecologic Cancer']}, 'referencesModule': {'references': [{'pmid': '12926578', 'type': 'RESULT', 'citation': "Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005."}, {'pmid': '31115262', 'type': 'RESULT', 'citation': 'Wang A, Cui G, Jin C, Wang Y, Tian X. Multicenter research on tumor and pregnancy outcomes in patients with early-stage cervical cancer after fertility-sparing surgery. J Int Med Res. 2019 Jul;47(7):2881-2889. doi: 10.1177/0300060519845974. Epub 2019 May 22.'}, {'pmid': '34769256', 'type': 'RESULT', 'citation': 'Gullo G, Etrusco A, Cucinella G, Perino A, Chiantera V, Lagana AS, Tomaiuolo R, Vitagliano A, Giampaolino P, Noventa M, Andrisani A, Buzzaccarini G. Fertility-Sparing Approach in Women Affected by Stage I and Low-Grade Endometrial Carcinoma: An Updated Overview. Int J Mol Sci. 2021 Oct 31;22(21):11825. doi: 10.3390/ijms222111825.'}, {'pmid': '25489139', 'type': 'RESULT', 'citation': 'Kovacs P. Fertility preservation in reproductive age women with cancer. J Obstet Gynaecol India. 2014 Dec;64(6):381-7. doi: 10.1007/s13224-014-0626-0. Epub 2014 Oct 30.'}, {'pmid': '25649243', 'type': 'RESULT', 'citation': 'Levine JM, Kelvin JF, Quinn GP, Gracia CR. Infertility in reproductive-age female cancer survivors. Cancer. 2015 May 15;121(10):1532-9. doi: 10.1002/cncr.29181. Epub 2015 Feb 3.'}]}, 'descriptionModule': {'briefSummary': "FSS which aims to preserve a woman's fertility while still effectively treating the cancer, has become an increasingly popular option for young women diagnosed with these types of cancers. It is important to assess how FSS affects a woman's reproductive health, sexual function, psychological well-being, and overall quality of life. This research aims to provide valuable insights into the long-term effects of FSS on a woman's life, and can help healthcare providers make informed decisions about the best treatment options for their patients.", 'detailedDescription': "This is a prospective cohort study that aims to evaluate the infertility and pregnancy outcomes, as well as the quality of life of women who underwent fertility-sparing surgery for gynecological malignancies. The study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods. Participants recruited from a tertiary care hospital, and women diagnosed with gynecological malignancies (e.g. cervical, ovarian, endometrial cancer) who underwent fertility-sparing surgery between 2010 and 2022. Women who have undergone total hysterectomy, bilateral salpingo-oophorectomy, or adjuvant oncological treatment were excluded from the study. Participants were contacted by phone and asked to complete questionnaires to assess their quality of life using the WHOQoL-BREF and FertiQoL scales."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of gynecologic cancer, and being fertile in the meantime\n* Applying directly to gynecologic oncology department\n* Demand of preserving the fertility\n\nExclusion Criteria:\n\n* Having hysterectomy prior to the diagnosis\n* Having bilateral ooferectomy prior to the diagnosis\n* Being in menopause\n* Not accepting to fill the survey\n* High stage disease which is not able to have FSS'}, 'identificationModule': {'nctId': 'NCT05823194', 'briefTitle': 'Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'The Evaluation of Infertility and Pregnancy Outcomes, as Well as the Assessment of Quality of Life Using WHOQoL and FertiQoL, in Cases of Gynecological Malignancies That Have Undergone Fertility-sparing Surgery(FSS)', 'orgStudyIdInfo': {'id': '2022-17/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fertility spared gynecologic cancer diagnosed women', 'description': 'Participants recruited from a tertiary care hospital, and women diagnosed with gynecological malignancies (e.g. cervical, ovarian, endometrial cancer) who underwent fertility-sparing surgery between 2010 and 2022.', 'interventionNames': ['Procedure: Fertility sparing surgery']}], 'interventions': [{'name': 'Fertility sparing surgery', 'type': 'PROCEDURE', 'description': "Sparing the uterus and/or ovaries of the patients suffering from gynecologic malignancies to keep the patients' fertility", 'armGroupLabels': ['Fertility spared gynecologic cancer diagnosed women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'NAZLI ALBAYRAK, MD', 'role': 'CONTACT', 'email': 'albayraknazli@gmail.com', 'phone': '00905054111626'}, {'name': 'NAZLI ALBAYRAK, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Acibadem Maslak Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'NAZLI ALBAYRAK, MD', 'role': 'CONTACT', 'email': 'albayraknazli@gmail.com', 'phone': '00905054111626'}], 'overallOfficials': [{'name': 'NAZLI ALBAYRAK, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Acibdem University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PGY-4 Ob/Gyn resident, MD', 'investigatorFullName': 'Nazli Albayrak', 'investigatorAffiliation': 'Acibadem University'}}}}