protocolSection identificationModule nctId: NCT06379659, orgStudyIdInfo id: IR.MUI.MED.REC.1402.449, secondaryIdInfos id: IRCT20110908007513N18, type: REGISTRY, domain: IRAN registry of clinical trials (IRCT), briefTitle: Effectiveness of Intrauterine Growth Hormone Administration as an add-on Therapy to Conventional Hormone Therapy Compared to Placebo in Patients With Thin Endometrium Undergoing Frozen Thawed Embryo Transfer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Isfahan University of Medical Sciences, class: OTHER, descriptionModule briefSummary: The purpose of this clinical trial is to see if intrauterine growth hormone infusions can help subjects reach a suitable endometrial thickness in patients who are resistant to routine hormonal therapy for embryo transfer in the In Vitro Fertilization (IVF) cycle.The primary aim of this study is to assess the effectiveness of injecting Growth hormone directly into the uterus to enhance endometrial thickness. Additionally, we aim to compare the likelihood of pregnancy between patients receiving the Growth hormone infusion and those receiving a placebo., conditionsModule conditions: Thin Endometrium, conditions: Infertility Female, conditions: Infertility, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study was designed as a randomized controlled exploratory clinical trial, controlled with a parallel placebo group and random allocation using an online based system., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: In this study, a double-blind methodology will be employed to minimize bias. Patients will be administered medication without knowing the study group and placebo or treatment intervention. To ensure uniformity between growth hormone and placebo, which has a similar appearance to the placebo, will be prepared by an individual informed of the enrolled patients in the study and will be provided to the administering physician. The evaluator assessing outcomes such as clinical pregnancy rate and endometrial thickness will not know which treatment each patient received. Laboratory staff will also be unaware of the treatment groups., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Growh hormone, interventions name: Placebo, outcomesModule primaryOutcomes measure: Endometrial thickness, secondaryOutcomes measure: Clinical Pregnancy Rate, secondaryOutcomes measure: Response to treatment, secondaryOutcomes measure: Implantation rate, secondaryOutcomes measure: IVF cancellation rate, secondaryOutcomes measure: Early pregnancy complications, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Isfahan Shahid Beheshti hospital, Hazrat e Maryam Fertility Center, status: RECRUITING, city: Isfahan, zip: 8174673461, country: Iran, Islamic Republic of, contacts name: Nastaran Zamani Dehkordi, role: CONTACT, phoneExt: +989133842958, email: nastaran14zd@gmail.com, contacts name: Hatav Ghasemi Dehkordi, role: CONTACT, phoneExt: +989131134081, email: hatav.tehrani2014@gmail.com, contacts name: Hatav Ghasemi Tehrani, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.65246, lon: 51.67462, hasResults: False