[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601294":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":55,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"hCG Priming","EXPERIMENTAL","Women in the experimental group will undergo the following treatment in order:\n\nA standard IVF\u002FICSI cycle (ICSI I): A standard IVF\u002FICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy.\n\nPriming period: hCG priming 260 IU once daily for two menstrual cycles (approximately 8 weeks).\n\nA standard IVF\u002FICSI cycle (ICSI I): A standard IVF\u002FICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a single blastocyst transfer at day 5.",[13],"Drug: Choriongonadotropin alfa (hCG)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Women in the placebo group will undergo the following treatment in order:\n\nA standard IVF\u002FICSI cycle (ICSI I): A standard IVF\u002FICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy.\n\nPriming period: Placebo (isotone NaCl) injections once daily for two menstrual cycles (approximately 8 weeks).\n\nA standard IVF\u002FICSI cycle (ICSI I): A standard IVF\u002FICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a single blastocyst transfer at day 5.",[19],"Drug: Isotonic NaCl (Placebo)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Choriongonadotropin alfa (hCG)","hCG 260 IU once daily for two menstrual cycles (aproximately 8 weeks) prior til standard IVF\u002FICSI.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Isotonic NaCl (Placebo)","Placebo priming (isotone NaCl) once daily for two menstrual cycles (approximately 8 weeks) prior to standard IVF\u002FICSI.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Kristine Løssl, Associate Professor, PhD, MD","CONTACT","+4535451077","kristine.loessl@regionh.dk",[38],{"facility":39,"status":40,"city":41,"state":26,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":26},"Fertility Clinic, Department of Gynaecology, Fertility and Obstetrics, Copenhagen University Hosital Rigshospitalet","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":46,"coordinates":47},"Point",[48,49],12.56553,55.67594,{"lat":49,"lon":48},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Kristine Loessl","Associate professor, Ph.D., MD",[56,58,60],{"name":57,"class":6},"Copenhagen University Hospital, Hvidovre",{"name":59,"class":6},"Copenhagen University Hospital at Herlev",{"name":61,"class":6},"Odense University Hospital","100601294","phase-3-hcg-priming-in-women-with-diminished-ovarian-reserve-100601294",false,"NCT07108621","hCG Priming in Women With Diminished Ovarian Reserve","Eight Weeks of Low Dose hCG Priming in Women With Diminished Ovarian Reserve Undergoing IVF\u002FICSI - a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18-40 (both inclusive)\n* Regular menstrual cycle (23-35 days)\n* 1.-5. IVF\u002FICSI cycle at inclusion\n* AMH \\\u003C 6.29 pmol\u002FL (Elecsys® AMH assay)\n\nExclusion Criteria:\n\n* Uterine malformations or hydrosalpinx\n* Submucosal uterine myomas\n* Uterine polyps\n* Allergy to standard IVF\u002FICSI medication\n* Endometriosis stage III-IV\n* Preimplantation genetic testing\n* Testicular sperm aspiration\u002Fextraction\n* Ovarian enlargement or cysts (other than normally occurring corpora luteae)\n* Gynaecological haemorrhages of unknown aetiology\n* Known severe comorbidity\\*\n\n  * i.e., Insulin dependent diabetes mellitus, non-insulin dependent diabetes mellitus, gastrointestinal, cardiovascular, thromboembolic (including active thromboembolic disorders), pulmonary, liver or kidney diseases, HIV or Hepatitis B\u002FC, dysregulated thyroid disease, tumors of the hypothalamus or pituitary gland or ovarian, uterine, or mammary carcinoma.","FEMALE","18 Years","40 Years",{"count":73,"type":74},80,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","The aim of this randomized controlled trial is to further examine the possible effects of low dose human chorionic gonadotropin (hCG) priming for eight weeks in women with diminished ovarian reserve (DOR) undergoing in vitro fertilization (IVF)\u002Fintracytoplasmic sperm injection (ICSI). The investigators want to retest the findings of our first study in an identical paired design (NCT04643925), as an increase of 1.5 in mean number of oocytes retrieved is clinically relevant. To incorporate the strengths of a randomized controlled trial design, women will be randomized after their first ICSI treatment to receive either hCG or placebo in a double-blinded design during an eight-week priming period preceding their second ICSI treatment. The primary outcome is the number of oocytes retrieved in the second ICSI treatment.",[80,81,82],"Infertility, Female","Ovarian Reserve","In Vitro Fertilization (IVF)",[84,85,86,87,88],"hCG priming","Androgen priming","Diminished ovarian reserve","In vitro fertilization (IVF)","Controlled ovarian stimulation","2025-09-10",{"date":91,"type":92},"2025-09-17","ACTUAL",{"date":94,"type":74},"2025-09",{"date":96,"type":74},"2031-03-31",{"name":53,"class":6},1]