[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429483":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":60,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Shandong University of Traditional Chinese Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GSATP group","EXPERIMENTAL","Gushen Antai Pill (GSATP, 6g\\* 9 bags, Beijing boran Pharmaceutical Inc.) was required to be taken orally, 6g three times daily combined with vaginal progesterone (90 mg\u002Fday Crinone, Merck) from the day of embryo transfer until 10th gestational week.",[13],"Drug: Gushen Antai Pill",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Placebo pill is made up of a certain amount of starch and glucose, and is shaped like GSATP according to the National Drug Standards of the State Food and Drug Administration of China. Placebo pill was required to be taken orally, 6g three times daily combined with vaginal progesterone (90 mg\u002Fday Crinone, Merck) from the day of embryo transfer until 10th gestational week.",[19],"Drug: Placebo pill",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Gushen Antai Pill","The Gushen Antai Pill (GSATP, Z20030144) is composed of 10 herbs including radix-polygoni multiflori, radix rehmanniae praeparata, cistanche salsa, radix dipsaci, uncaria, semen cuscutae, rhizoma atractylodis macrocephalae, radix scutellariae, radix paeoniae lactiflorae. Its production follows GMP standards and takes the form of water honey pills, each bag of 6g.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo pill","The placebo pill is produced by Beijing boran Pharmaceutical Co., Ltd. It can simulate the appearance, color and smell of GSATP formula, but it has no clinical effect because it has no active ingredients.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Zhen-Gao Sun, M.D.","CONTACT","+86-13708938621","sunzhengao77@126.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Jing-Yan Song, M.D.","+86-1876580013","hanlingjuzei91@126.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The Affiliated Hospital of Shandong University of Traditional Chinese Medicine","RECRUITING","Jinan","Shandong","250014","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.99722,36.66833,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":59,"phoneExt":26,"email":36},"Zhen-Gao Sun, PhD","+8613708938621",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jing-Yan Song","Principal Investigator","100429483","phase-4-efficacy-and-safety-of-gushen-antai-pill-on-ongoing-pregnancy-rate-in-women-with-normal-ovarian-reserve-undergoing-ivf-et-100429483",false,"NCT04872660","Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing IVF-ET","Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing in Vitro Fertilization Embryo Transfer: A Prospective, Multicentre, Randomised, Double-blind, Placebo-controlled Trial","GSATP-FreET","Inclusion Criteria:\n\n* Patients with normal ovarian function reserve (5 ≤ AFC ≤ 15, 1.2 ng\u002Fml ≤ AMH ≤ 3.5 ng\u002Fml).\n* Patients with regular menstrual cycle (21-35 days) and normal ovulation.\n* Initial IVF \u002F ICSI treatment.\n* At least one embryo or blastocyst available for transfer.\n\nExclusion Criteria:\n\n* Age ≥ 43 years old.\n* Body mass index (BMI) ≥ 28 Kg\u002Fm2.\n* \"Freeze-all\" strategy.\n* Those using the natural cycle or mild stimulation for IVF\u002FICSI treatment.\n* Individuals with severe hyperstimulation ovarian syndrome during controlled ovarian stimulation.\n* Acceptors of donated oocytes or performed either In vitro Maturation (IVM) or blastocyst biopsy for Preimplantation Genetic Diagnosis (PGD) or Preimplantation Genetic Testing for Aneuploidies (PGT-A).\n* History of two or more previous consecutive spontaneous abortions.\n* History of two or more previous IVF-ET failures.\n* Karyotype abnormalities.\n* Polycystic ovary syndrome.\n* Presence of a non-surgically treated hydrosalpinx, uterine cavity fluid or endometrial polyp and an ovarian endometriosis cyst requiring surgery, during ovarian stimulation.\n* Congenital or acquired abnormalities of uterine anatomy.\n* Combined contraindications to assisted reproductive technology or pregnancy, such as uncontrolled abnormalities of liver and kidney function, diabetes mellitus (glycosylated haemoglobin ≤7%, fasting blood glucose \\\u003C10 mmol\u002FL ), hypertension, thyroid disease, symptomatic heart disease, moderate to severe anaemia, history of malignancy or thromboembolism or propensity to thrombosis, severe psychiatric disorder, acute infections of the genitourinary system, sexually transmitted diseases, serious adverse habits such as drug abuse, exposure to teratogenic amounts of radiation, toxins, or drugs (such as prednisone or other hormones, adrenaline, antibiotics, or hypertension, cardiovascular, or antiviral medications) during the active procedure period , and uterine factor infertility or physical illness which prevents the ability to bear a pregnancy.","FEMALE","21 Years","42 Years",{"count":76,"type":77},800,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","The purpose of this study is to investigate whether oral Gushen Antai pills supplementation for luteal phase support will improve ongoing pregnancy rate in women with normal ovarian reserve in fresh embryo transfer cycles.",[83],"Infertility, Female",[85,86,23,87,88],"Traditional Chinese Medicine","In vitro fertilization-embryo transfer","Normal ovarian reserve","Ongoing pregnancy rate","2026-03-06",{"date":91,"type":92},"2026-03-10","ACTUAL",{"date":94,"type":92},"2021-06-15",{"date":96,"type":77},"2026-12-30",{"name":5,"class":6},1]