Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 4:58 PM
Study NCT ID:
NCT07340827
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062876', 'term': 'cetrorelix'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 333}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of oocytes retrieved', 'timeFrame': 'At approximately 36 to 38 hours after r-hCG administration (Day 4)', 'description': 'Mean number of oocytes retrieved will be calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.'}], 'secondaryOutcomes': [{'measure': 'Total dose of gonadotropin (IU) used', 'timeFrame': 'At Visit 3 after ovarian stimulation from Day 5 until Day of r-hCG (maximum 18 days)', 'description': 'Total dose of Human Menopausal Gonadotropin (hMG) referred as IU of FSH.'}, {'measure': 'Number of Days of Gonadotropin Treatment', 'timeFrame': 'At Visit 3 after ovarian stimulation from Day 5-18', 'description': 'Total number of days of ovarian stimulation will be reported.'}, {'measure': 'Total Number of Follicles Measuring greater than or equal to 14 millimeter (mm) and greater than or equal to 17 mm in diameter', 'timeFrame': 'During Ovarian stimulation (Day 5 to Day 18)'}, {'measure': 'Serum Estradiol (E2) levels', 'timeFrame': 'At Visit 3 after ovarian stimulation from Day 5-18'}, {'measure': 'Proportion of 2 Pronuclei Embryos/Fertilized Oocytes', 'timeFrame': 'At 18 (Plus or minus two hours) hours after insemination', 'description': 'The proportion of oocytes that fertilized after they were inseminated with the sperm will be reported.'}, {'measure': 'Number of blastocysts frozen', 'timeFrame': '5 days after insemination', 'description': 'After the transfer of 1 fresh blastocysts - spare ones will be frozen.'}, {'measure': 'Number of Participants With Clinical Pregnancy', 'timeFrame': '35-42 days after Visit 5 (Blastocyst transfer)', 'description': 'A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or with or without heartbeat (fetal sac).'}, {'measure': 'Number of Participants With Ongoing Pregnancy', 'timeFrame': 'up to 80 days after blastocyst transfer (pregnancy week 11 to 12)', 'description': 'Ongoing pregnancy will be confirmed with transvaginal ultrasound (TVUS) showing heartbeat.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events and Treatment related Adverse Events', 'timeFrame': '5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy'}, {'measure': 'Number of Participants With Ovarian Hyperstimulation Syndrome (OHSS)', 'timeFrame': '5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy'}, {'measure': 'Number of Participants With Mild, Moderate, and Severe Ovarian Hyperstimulation Syndrome', 'timeFrame': '5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy'}, {'measure': 'Number of Cycles Cancelled due to Risk of Ovarian Hyperstimulation Syndrome', 'timeFrame': '5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy'}, {'measure': 'Number of Participants With Clinically Significant Changes in Laboratory Parameters and Vital Signs', 'timeFrame': '5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy'}, {'measure': 'Number of Participants Experiencing Local Reactions', 'timeFrame': '5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy', 'description': 'Pain redness, swelling, bruising, and itching around the injection site will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gonadotropins, infertility, prefilled pen'], 'conditions': ['Infertility']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.emdgroup.com/en/trial-details/_en', 'label': 'Trial Awareness and Transparency website'}, {'url': 'https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html', 'label': 'Medical Information Location Map - Med Info Contacts'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART).\n\nThe study duration is approximately 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy in Part A.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who are premenopausal wishing to conceive\n* Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy\n* Japanese Participants\n* Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency congenital or acquired\n* Participants have a vaginal ultrasound scan showing both ovaries and no clinically significant uterine abnormality and a normal antral follicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) in diameter per ovary\n* A semen analysis of the male partner been performed within 3 months prior to signature of informed consent and suitable for assisted reproductive technology\n* Participants have a normal cervical ThinPrep® cytologic test, (TCT) or Pap smear within 12 months of Screening. If not available, a cervical smear will be performed as part of screening\n* Other protocol defined criteria may apply\n\nExclusion Criteria:\n\n* Participants with history of severe OHSS in any previous ovarian stimulation cycle\n* Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modified definition\n* Participants with contraindication to treatment with gonadotropins, hypersensitivity to gonadotropins or to any of the excipients\n* Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, or mammary carcinoma)\n* Participants with ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 millimeters before Day 1\n* other protocol defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT07340827', 'briefTitle': 'A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Parallel-group Treatment, 2-arm Study to Compare the Efficacy and Safety of Follitropin Alfa and Lutropin Alfa Fixed Dose Combination Versus hMG for Inducing Follicular Development in Japanese Participants With LH and FSH Deficiency Undergoing ART', 'orgStudyIdInfo': {'id': 'MS132705_0007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Follitropin alfa/lutropin alfa', 'description': 'Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio.', 'interventionNames': ['Combination Product: Follitropin alfa/lutropin alfa (MBJ-0011)', 'Drug: Cetrorelix acetate', 'Drug: Coriogonadotropin alfa', 'Drug: Progesterone gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Human Menopausal Gonadotropin (hMG)', 'interventionNames': ['Drug: hMG', 'Drug: Cetrorelix acetate', 'Drug: Coriogonadotropin alfa', 'Drug: Progesterone gel']}], 'interventions': [{'name': 'Follitropin alfa/lutropin alfa (MBJ-0011)', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['MBJ-0011', 'r-hFSH/r-hLH'], 'description': 'Follitropin alfa and lutropin alfa will be administered subcutaneously once daily with a starting dose of 150 International Unit (IU) of follitropin alfa, 75 IU of lutropin alfa, in ovarian stimulation up to 18 days.', 'armGroupLabels': ['Arm 1: Follitropin alfa/lutropin alfa']}, {'name': 'hMG', 'type': 'DRUG', 'description': 'Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.', 'armGroupLabels': ['Arm 2: Human Menopausal Gonadotropin (hMG)']}, {'name': 'Cetrorelix acetate', 'type': 'DRUG', 'otherNames': ['GnRH', 'antagonist'], 'description': 'Participants will receive 250 micrograms (mcg) of Cetrorelix acetate as Powder for reconstitution to a solution for injection with diluent in ampule, daily from Day 5 or 6 of stimulation up to the day of r-hCG.', 'armGroupLabels': ['Arm 1: Follitropin alfa/lutropin alfa', 'Arm 2: Human Menopausal Gonadotropin (hMG)']}, {'name': 'Coriogonadotropin alfa', 'type': 'DRUG', 'otherNames': ['r-hCG'], 'description': 'Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.', 'armGroupLabels': ['Arm 1: Follitropin alfa/lutropin alfa', 'Arm 2: Human Menopausal Gonadotropin (hMG)']}, {'name': 'Progesterone gel', 'type': 'DRUG', 'description': 'Participants will self-administer progesterone gel 8 percent, with an applicator, at a dose of 90 milligram (mg), intravaginally, daily from oocyte retrieval during Luteal phase support.', 'armGroupLabels': ['Arm 1: Follitropin alfa/lutropin alfa', 'Arm 2: Human Menopausal Gonadotropin (hMG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '261-8501', 'city': 'Chiba', 'state': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'kawaikiyotaka@wfc-mom.jp'}, {'name': 'Kiyotaka Kawai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '371-0031', 'city': 'Maebashi', 'state': 'Gunma', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'yoshimasa0709yokota@gmail.com'}, {'name': 'Yoshimasa Yokota', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '060-0003', 'city': 'Sapporo', 'state': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'nanakoiwami@gmail.com'}, {'name': 'Nanako Iwami', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kamiya Ladies Clinic - Dept of Gynecology', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '650-0021', 'city': 'Kobe', 'state': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'kokeguchi@hanabusaclinic.com'}, {'name': 'Shoji Kokeguchi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology", 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '252-0233', 'city': 'Sagamihara-shi', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'hase009@sophia-lc.jp'}, {'name': 'Tomoya Hasegawa', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sophia Ladies Clinic - Dept of Obstetrics/Gynecology'}, {'zip': '780-0072', 'city': 'Kochi', 'state': 'Kochi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'ch.kuwahara@lccosmos.jp'}, {'name': 'Akira Kuwahara', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ladies Clinic Cosmos - Dept of Infertility Treatment', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': '388-8004', 'city': 'Nagano', 'state': 'Nagano', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'ryohei-n@yg8.so-net.ne.jp'}, {'name': 'Ryohei Nishimura', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '577-0012', 'city': 'Higashiosaka-shi', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'chiken2026@yahoo.co.jp'}, {'name': 'Aisaku Fukuda', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology'}, {'zip': '330-0855', 'city': 'Saitama-shi', 'state': 'Saitama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'yujiy1012@yahoo.co.jp'}, {'name': 'Yuji Kashiwazaki', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology'}, {'zip': '113-8655', 'city': 'Bunkyō City', 'state': 'Tokyo-To', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'haradamtky@gmail.com'}, {'name': 'Miyuki Harada', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Tokyo Hospital - Dept of Obstetrics', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}], 'centralContacts': [{'name': 'Communication Center', 'role': 'CONTACT', 'email': 'service@emdgroup.com', 'phone': '+49 6151 72 5200'}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'ipdSharingStatementModule': {'url': 'http://bit.ly/IPD21', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union.', 'ipdSharing': 'YES', 'description': 'We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21.', 'accessCriteria': "Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}