Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT07128394
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extra Luteinizing Hormone Improve Embryo Quality in IVF Patients With Low LH During Long GnRH-Agonist Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], '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'}, {'id': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007986', 'term': 'Luteinizing Hormone'}, {'id': 'D037101', 'term': 'Luteinizing Hormone, beta Subunit'}, {'id': 'D015292', 'term': 'Glycoprotein Hormones, alpha Subunit'}, {'id': 'C571801', 'term': 'follitropin alfa'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D017329', 'term': 'Triptorelin Pamoate'}], 'ancestors': [{'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'D005640', 'term': 'Follicle Stimulating Hormone'}, {'id': 'D013972', 'term': 'Thyrotropin'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'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', 'maskingDescription': 'Not applicable. This is an open-label trial in which both participants and investigators are aware of the assigned interventions.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned in a 1:1 ratio to either the intervention group receiving exogenous luteinizing hormone (LH) supplementation in addition to the standard long GnRH agonist protocol, or the control group receiving the standard long GnRH agonist protocol without LH supplementation. Both groups will undergo controlled ovarian stimulation and in vitro fertilization (IVF) according to the study protocol.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 590}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of cycles with no usable embryos', 'timeFrame': '7 days after oocyte retrieval', 'description': 'The number of IVF/ICSI cycles with no transferable embryos divided by the total number of oocyte retrieval cycles, evaluated based on embryo morphology and grading on Day 3 or Day 5-6 after fertilization.'}], 'secondaryOutcomes': [{'measure': 'Number of high-quality Day 3 embryos', 'timeFrame': '7 days after oocyte retrieval', 'description': 'Count of embryos meeting morphological criteria for high quality on Day 3 after fertilization, as determined by standard embryology scoring.'}, {'measure': 'Total gonadotropin dose used', 'timeFrame': 'At the end of ovarian stimulation (average 8-12 days)', 'description': 'Cumulative dose (IU) of gonadotropins administered from stimulation start to trigger day.'}, {'measure': 'Duration of gonadotropin stimulation', 'timeFrame': 'At the end of ovarian stimulation (average 8-12 days)', 'description': 'Number of days from gonadotropin initiation to trigger day.'}, {'measure': 'Number of oocytes retrieved', 'timeFrame': 'At oocyte retrieval (36-38 hours after trigger)', 'description': 'Total number of oocytes collected during transvaginal ultrasound-guided oocyte retrieval.'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '30 days after embryo transfer', 'description': 'Proportion of embryo transfer cycles resulting in at least one intrauterine gestational sac with fetal heartbeat, confirmed by transvaginal ultrasound.'}, {'measure': 'Early miscarriage rate', 'timeFrame': 'Within 12 weeks of gestation', 'description': 'Proportion of clinical pregnancies ending in miscarriage before 12 completed weeks of gestation.'}, {'measure': 'Live birth rate', 'timeFrame': 'At delivery (up to 1 year after embryo transfer)', 'description': 'Proportion of embryo transfer cycles resulting in the delivery of at least one live-born infant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Luteinizing Hormone', 'Long GnRH Agonist Protocol', 'Excessive LH Suppression', 'Controlled Ovarian Stimulation', 'In Vitro Fertilization', 'Embryo Quality'], 'conditions': ['Infertility, Female', 'Luteinizing Hormone (LH)']}, 'referencesModule': {'references': [{'pmid': '25237892', 'type': 'BACKGROUND', 'citation': 'Yazici Yilmaz F, Gorkemli H, Colakoglu MC, Aktan M, Gezginc K. The evaluation of recombinant LH supplementation in patients with suboptimal response to recombinant FSH undergoing IVF treatment with GnRH agonist down-regulation. Gynecol Endocrinol. 2015 Feb;31(2):141-4. doi: 10.3109/09513590.2014.965675. Epub 2014 Sep 19.'}, {'pmid': '12456612', 'type': 'BACKGROUND', 'citation': 'Tesarik J, Mendoza C. Effects of exogenous LH administration during ovarian stimulation of pituitary down-regulated young oocyte donors on oocyte yield and developmental competence. Hum Reprod. 2002 Dec;17(12):3129-37. doi: 10.1093/humrep/17.12.3129.'}, {'pmid': '3108319', 'type': 'BACKGROUND', 'citation': 'Wu KK, Papp AC, Manner CE, Hall ER. Interaction between lymphocytes and platelets in the synthesis of prostacyclin. J Clin Invest. 1987 Jun;79(6):1601-6. doi: 10.1172/JCI112995.'}, {'pmid': '30973022', 'type': 'BACKGROUND', 'citation': 'Kan O, Simsir C, Atabekoglu CS, Sonmezer M. The impact of adding hp-hMG in r-FSH started GnRH antagonist cycles on ART outcome. Gynecol Endocrinol. 2019 Oct;35(10):869-872. doi: 10.1080/09513590.2019.1600667. Epub 2019 Apr 11.'}, {'pmid': '21839437', 'type': 'BACKGROUND', 'citation': 'Propst AM, Hill MJ, Bates GW, Palumbo M, Van Horne AK, Retzloff MG. Low-dose human chorionic gonadotropin may improve in vitro fertilization cycle outcomes in patients with low luteinizing hormone levels after gonadotropin-releasing hormone antagonist administration. Fertil Steril. 2011 Oct;96(4):898-904. doi: 10.1016/j.fertnstert.2011.06.069. Epub 2011 Aug 11.'}, {'pmid': '31110533', 'type': 'BACKGROUND', 'citation': 'Tayyar AT, Kahraman S. Comparison between cycles of the same patients when using recombinant luteinizing hormone + recombinant follicle stimulating hormone (rFSH), human menopausal gonadotropin + rFSH and rFSH only. Arch Med Sci. 2019 May;15(3):673-679. doi: 10.5114/aoms.2017.72408. Epub 2018 Jan 8.'}, {'pmid': '10875848', 'type': 'BACKGROUND', 'citation': 'Fleming R, Rehka P, Deshpande N, Jamieson ME, Yates RW, Lyall H. Suppression of LH during ovarian stimulation: effects differ in cycles stimulated with purified urinary FSH and recombinant FSH. Hum Reprod. 2000 Jul;15(7):1440-5. doi: 10.1093/humrep/15.7.1440.'}, {'pmid': '10783342', 'type': 'BACKGROUND', 'citation': 'Westergaard LG, Laursen SB, Andersen CY. Increased risk of early pregnancy loss by profound suppression of luteinizing hormone during ovarian stimulation in normogonadotrophic women undergoing assisted reproduction. Hum Reprod. 2000 May;15(5):1003-8. doi: 10.1093/humrep/15.5.1003.'}, {'pmid': '16790105', 'type': 'BACKGROUND', 'citation': 'Alviggi C, Clarizia R, Mollo A, Ranieri A, De Placido G. Outlook: who needs LH in ovarian stimulation? Reprod Biomed Online. 2006 May;12(5):599-607. doi: 10.1016/s1472-6483(10)61186-8.'}, {'pmid': '32470947', 'type': 'BACKGROUND', 'citation': 'Li F, Ye T, Kong H, Li J, Hu L, Jin H, Su Y, Li G. Efficacies of different ovarian hyperstimulation protocols in poor ovarian responders classified by the POSEIDON criteria. Aging (Albany NY). 2020 May 29;12(10):9354-9364. doi: 10.18632/aging.103210. Epub 2020 May 29.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to evaluate whether supplementation with exogenous luteinizing hormone (LH) can improve embryo quality in patients undergoing in vitro fertilization (IVF) with a long gonadotropin-releasing hormone agonist (GnRH-a) protocol who have excessive suppression of LH. Eligible participants will be randomly assigned to receive either exogenous LH supplementation or standard care. The primary outcome is embryo quality, and secondary outcomes include pregnancy rates and safety assessments. The study is conducted at Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University.', 'detailedDescription': 'Excessive suppression of luteinizing hormone (LH) during ovarian stimulation with a long gonadotropin-releasing hormone agonist (GnRH-a) protocol has been associated with suboptimal follicular development, impaired oocyte maturation, and reduced embryo quality. LH plays a critical role in the final stages of folliculogenesis, steroidogenesis, and ovulation, and its deficiency during controlled ovarian hyperstimulation may adversely affect the developmental competence of oocytes.\n\nThis randomized controlled trial is designed to evaluate whether supplementation with exogenous LH can improve embryo quality in patients undergoing in vitro fertilization (IVF) with excessive LH suppression during a long GnRH-a protocol. Eligible participants are women meeting predefined hormonal suppression criteria prior to or during stimulation. Participants will be randomly assigned to receive either exogenous LH supplementation in addition to standard ovarian stimulation or standard care without LH supplementation.\n\nThe primary endpoint is the proportion of high-quality embryos obtained per cycle. Secondary endpoints include clinical pregnancy rate, implantation rate, live birth rate, and safety outcomes such as incidence of ovarian hyperstimulation syndrome (OHSS) and adverse events.\n\nThe study aims to provide high-quality evidence to guide the optimal management of patients with profound LH suppression during controlled ovarian stimulation. Findings from this trial may contribute to refining stimulation protocols and improving reproductive outcomes in assisted reproductive technology (ART).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': "Eligibility is limited to biological females of reproductive age due to the study's focus on ovarian stimulation and embryo quality in IVF/ICSI cycles.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 20 to 37 years (inclusive). Diagnosed with infertility and undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment using the long-acting GnRH agonist protocol.\n\nSerum luteinizing hormone (LH) level \\<0.5 U/L after pituitary downregulation. Normal uterine cavity as confirmed by hysteroscopy, sonohysterography, or hysterosalpingography within 6 months.\n\nWritten informed consent provided prior to participation.\n\nExclusion Criteria:\n\n* Polycystic ovary syndrome (PCOS). History of recurrent implantation failure (RIF). Presence of endometriosis or adenomyosis. History of ovarian surgery. Ovarian cysts ≥3 cm or with suspected malignancy. Poor ovarian reserve (antral follicle count \\<5, anti-Müllerian hormone \\<1.1 ng/mL, or baseline FSH \\>10 IU/L).\n\nChromosomal abnormalities in either partner. Systemic diseases such as uncontrolled hypertension, diabetes, thyroid disorders, or autoimmune diseases.\n\nContraindications to ovarian stimulation medications or pregnancy.'}, 'identificationModule': {'nctId': 'NCT07128394', 'acronym': 'ELH-IVF', 'briefTitle': 'Extra Luteinizing Hormone Improve Embryo Quality in IVF Patients With Low LH During Long GnRH-Agonist Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing University'}, 'officialTitle': 'Exogenous Luteinizing Hormone Supplementation to Improve Embryo Quality in Patients With Excessive LH Suppression During a Long GnRH-Agonist Protocol: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SZ-ELH-2025'}, 'secondaryIdInfos': [{'id': 'BJHPA-2023-SZHYXZHQN-006', 'type': 'OTHER', 'domain': 'Beijing Health Sponsoring Organization'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recombinant LH Supplementation Group', 'description': 'Participants receive controlled ovarian hyperstimulation (COH) using a long-acting GnRH agonist (triptorelin 3.75 mg) for pituitary downregulation, followed by recombinant FSH (rFSH) combined with recombinant LH (rLH) at a ratio of 2:1 starting on stimulation day. rLH administration continues throughout the stimulation phase, with gonadotropin doses adjusted based on follicular growth and hormone monitoring. Trigger is given when 2-3 leading follicles reach ≥18 mm, followed by oocyte retrieval, IVF/ICSI, and embryo quality assessment.', 'interventionNames': ['Drug: Recombinant Luteinizing Hormone (rLH)', 'Drug: Recombinant Follicle-Stimulating Hormone (rFSH)', 'Drug: Gonadotropin-Releasing Hormone Agonist (GnRH-a)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional rFSH-Only Group', 'description': 'Participants receive the same long-acting GnRH agonist downregulation and rFSH stimulation protocol as the experimental arm, but without rLH supplementation. Only rFSH is used during COH, with dose adjustments according to follicular development and hormone levels. Trigger, oocyte retrieval, IVF/ICSI, and embryo assessment follow the same procedures as in the experimental arm.', 'interventionNames': ['Drug: Recombinant Follicle-Stimulating Hormone (rFSH)', 'Drug: Gonadotropin-Releasing Hormone Agonist (GnRH-a)']}], 'interventions': [{'name': 'Recombinant Luteinizing Hormone (rLH)', 'type': 'DRUG', 'otherNames': ['lutropin alfa', 'Luveris'], 'description': 'Recombinant LH administered subcutaneously in combination with recombinant FSH (rFSH) at a ratio of 2:1 starting on stimulation day, continued throughout controlled ovarian hyperstimulation. Dosage adjusted according to follicular growth and serum hormone levels.', 'armGroupLabels': ['Recombinant LH Supplementation Group']}, {'name': 'Recombinant Follicle-Stimulating Hormone (rFSH)', 'type': 'DRUG', 'otherNames': ['follitropin alfa', 'Gonal-F'], 'description': 'Recombinant FSH administered subcutaneously for controlled ovarian hyperstimulation after pituitary downregulation with a long-acting GnRH agonist. Dosage adjusted based on follicular development and hormone monitoring.', 'armGroupLabels': ['Conventional rFSH-Only Group', 'Recombinant LH Supplementation Group']}, {'name': 'Gonadotropin-Releasing Hormone Agonist (GnRH-a)', 'type': 'DRUG', 'otherNames': ['triptorelin', 'Diphereline'], 'description': 'Long-acting GnRH agonist (3.75 mg) administered subcutaneously on menstrual cycle day 2-4 for pituitary downregulation before controlled ovarian hyperstimulation.', 'armGroupLabels': ['Conventional rFSH-Only Group', 'Recombinant LH Supplementation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yue Jiang, PhD', 'role': 'CONTACT', 'email': 'jiangyue85@163.com', 'phone': '+8613814122872'}, {'name': 'Hui Zhang, PhD', 'role': 'CONTACT', 'email': 'hellozhanghui@sina.cn', 'phone': '+8618262637731'}, {'name': 'Yue Jiang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing Drum Tower Hospital, Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yue Jiang, PhD', 'role': 'CONTACT', 'email': 'jiangyue85@163.com', 'phone': '+8613814122872'}, {'name': 'Hui Zhang, PhD', 'role': 'CONTACT', 'email': 'hellozhanghui@sina.cn', 'phone': '+8618262637731'}], 'overallOfficials': [{'name': '慧 Jiang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to concerns regarding patient privacy, confidentiality, and compliance with local regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University', 'investigatorFullName': 'Li-jun Ding', 'investigatorAffiliation': 'Nanjing University'}}}}