Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-01 @ 10:43 PM
Study NCT ID:
NCT06379659
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], '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.'}, 'primaryPurpose': 'TREATMENT', '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-14', 'studyFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2024-04-19', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endometrial thickness', 'timeFrame': 'Baseline (On the 10th day of menstrual cycle), and On the day of response to treatment (in case of response) and in case of non-response to treatment on the 18th day of the mesntrual cycle', 'description': "Measurement of endometrial thickness will be performed utilizing transvaginal sonography due to its closer proximity to the endometrium and with an empty bladder. To minimize the potential bias of measuring endometrial thickness during uterus contraction, occur during contractions, measurements will be taken only after the patient's contractions have ceased."}], 'secondaryOutcomes': [{'measure': 'Clinical Pregnancy Rate', 'timeFrame': '6-8 of gestational week', 'description': 'The number of fetuses that have a heartbeat and are not ectopic evaluated by Transvaginal Ultrasonography'}, {'measure': 'Response to treatment', 'timeFrame': '2 days following the last dose of placebo or growth hormone', 'description': 'The number of patients that reach at least 7 mm of endometrial thickness'}, {'measure': 'Implantation rate', 'timeFrame': '6-8 of gestational week', 'description': 'The number of gestational sacs to the number of transferred embryos evaluated by Transvaginal ultrasonography'}, {'measure': 'IVF cancellation rate', 'timeFrame': '2 days following the last dose of placebo or growth hormone', 'description': 'The number of patients who do not reach enough endometrial thickness for transferring despite maximum treatment'}, {'measure': 'Early pregnancy complications', 'timeFrame': 'During the first 12 weeks of pregnancy', 'description': 'Including early miscarriage (miscarriage in less than 12th gestational week) and Ectopic pregnancy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infertility', 'Infertility, Female', 'endometrial thickness', 'Thin Endoetrium', 'Growth Hormone', 'Human Growth Hormone', 'Somatropin', 'Intra-uterine infusion'], 'conditions': ['Thin Endometrium', 'Infertility Female', 'Infertility']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Yu H, Gao S, Tang H, Chen H, Deng Z, Yang L, et al. Growth hormone intrauterine perfusion combined with replacement cycle in the treatment of non-response thin endometrium: report of 5 cases. Int J Clin Exp Med. 2016;9(6):11982-9'}, {'pmid': '36273309', 'type': 'RESULT', 'citation': 'Hosseini Aghdam S, Ghasemzadeh A, Farzadi L, Hamdi K, Baradaran-Binazir M, Nouri M, Fattahi A, Dttrich R. Growth Hormone: A Potential Treatment of Patients with Refractory Thin Endometrium: A Clinical Trial Study. Int J Fertil Steril. 2022 Oct 9;16(4):251-255. doi: 10.22074/ijfs.2022.541389.1210.'}, {'pmid': '34532462', 'type': 'RESULT', 'citation': 'Li W, Cao Z, Yu X, Hu W. Effect of growth hormone on thin endometrium via intrauterine infusion. Ann Transl Med. 2021 Aug;9(16):1325. doi: 10.21037/atm-21-3583.'}, {'pmid': '31616379', 'type': 'RESULT', 'citation': 'Altmae S, Aghajanova L. Growth Hormone and Endometrial Receptivity. Front Endocrinol (Lausanne). 2019 Sep 24;10:653. doi: 10.3389/fendo.2019.00653. eCollection 2019.'}, {'pmid': '31029557', 'type': 'RESULT', 'citation': 'Liu KE, Hartman M, Hartman A. Management of thin endometrium in assisted reproduction: a clinical practice guideline from the Canadian Fertility and Andrology Society. Reprod Biomed Online. 2019 Jul;39(1):49-62. doi: 10.1016/j.rbmo.2019.02.013. Epub 2019 Mar 20.'}, {'pmid': '37013570', 'type': 'RESULT', 'citation': 'Fu LL, Xu Y, Yan J, Zhang XY, Li DD, Zheng LW. Efficacy of granulocyte colony-stimulating factor for infertility undergoing IVF: a systematic review and meta-analysis. Reprod Biol Endocrinol. 2023 Apr 3;21(1):34. doi: 10.1186/s12958-023-01063-z.'}]}, '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.\n\nThe 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.', 'detailedDescription': 'Infertility impacts approximately 10-15% of couples globally, with over 1 million couples affected in Iran alone, adversely affecting their quality of life. However, Assisted Reproductive Technology (ART), notably In Vitro Fertilization (IVF), has markedly enhanced fertility outcomes for couples facing infertility.\n\nThe primary reason for IVF failure is often attributed to difficulties with embryo implantation. A crucial determinant in preparing the uterus for successful implantation is achieving an adequate endometrial thickness. A thin endometrium, typically defined as less than 7 mm in thickness, is associated with a significantly reduced likelihood of successful pregnancy following implantation. As a result, patients with thin endometrium are often deemed unsuitable candidates for implantation.\n\nDespite exploring various pharmacological options, certain patients remain unable to achieve the minimum required endometrial thickness for successful implantation. Prior investigations have examined the impact of subcutaneous growth hormone injections on endometrial thickness in individuals with thin endometrium, yielding mixed results across studies. Direct infusion of drugs into the uterine cavity presents a potential route for localized treatment, thereby minimizing systemic effects under specific circumstances. Thus, different studies explored the possible intra-uterine effect of drugs such as Granulocyte colony stimulating factor (GCSF), and Human chorionic gonadotropin (hCG). To date, only an animal study and two small studies without control group have investigated the efficacy of direct intrauterine infusion of growth hormone in increasing endometrial thickness among patients with thin endometrium. However, the absence of randomized controlled trials with placebo groups limits our understanding of the effectiveness of intrauterine growth hormone therapy in this patient population. Thus, we aimed to design an exploratory randomized clinical trial with parallel placebo group to evaluate the effectiveness of intrauterine Growth Hormone infusion as an add-on therapy to conventional hormone therapy compared to placebo in patients with thin endometrium undergoing frozen thawed embryo transfer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least a history of cycle cancellation due to a thin endometrium less than 7 mm following standard hormonal treatment\n* Availability of ≥1 embryo with good quality\n* Normal baseline hormones value including: Testosterone, Progesterone, Prolactin, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH)\n\nExclusion Criteria:\n\n* Internal genital anomalies\n* Active intrauterine infection Endometrial thickness≥7 on the 10th day of menstrual cycle\n* History of Asherman syndrome\n* History of cancer\n* History of uterine surgery in past 3 months\n* Intrauterine polyps visible in Transvaginal Ultrasonography\n* Visible intrauterine adhesion\n* Pathospermia in partner\n* Premature ovarian failure'}, 'identificationModule': {'nctId': 'NCT06379659', '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', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Effectiveness of Intrauterine Growth Hormone Infusion as an add-on Therapy to Conventional Hormone Therapy Compared to Placebo in Patients With Thin Endometrium Undergoing Frozen Thawed Embryo Transfer: A Double-blinded Parallel Exploratory Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'IR.MUI.MED.REC.1402.449'}, 'secondaryIdInfos': [{'id': 'IRCT20110908007513N18', 'type': 'REGISTRY', 'domain': 'IRAN registry of clinical trials (IRCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Growth hormone', 'interventionNames': ['Drug: Growh hormone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Growh hormone', 'type': 'DRUG', 'description': 'In this group, patients will receive growth hormone solution containing 1.99 milligrams of the drug dissolved in 1.5 milliliters of 0.9% saline solution (normal saline), in addition to standard hormonal therapy, starting from cycle day 10. Treatment sessions will be conducted at two-day intervals. In case of non-response to treatment (failure to reach a minimum endometrial thickness of 7 millimeters in the subsequent assessment), the patient will receive a maximum of 4 doses, and if response to treatment is observed, growth hormone infusion will be discontinued. All infusions will be administered intrauterinely via an Intrauterine Insemination (IUI) catheter.', 'armGroupLabels': ['Growth hormone']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Similar to the intervention group, from cycle day 10, an equal volume of 0.9% saline solution (normal saline) will be administered in addition to standard hormonal therapy. Treatment sessions will be conducted at two-day intervals. In case of non-response to treatment (failure to reach a minimum endometrial thickness of 7 millimeters in the subsequent assessment), the patient will receive a maximum of 4 doses, and if response to treatment is observed, placebo infusion will be discontinued. All infusions will be administered intrauterinely via an Intrauterine Insemination (IUI) catheter.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8174673461', 'city': 'Isfahan', 'country': 'Iran', 'facility': 'Isfahan Shahid Beheshti hospital, Hazrat e Maryam Fertility Center', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data (IPD) may be shared following the publication of the study, as per specific requests from the researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Associated professor of Infertility and In-Vivo-Fertilization', 'investigatorFullName': 'Hatav Ghasemi Tehrani', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}