[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527664":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ovulation triggering with hCG + Luteal phase support with vaginal progesterone","ACTIVE_COMPARATOR","hCG 250µg subcutaneously between 36h and 38h before oocyte retrieval + Progesterone 600mg\u002Fd (200mg tid) vaginally from the evening of the oocyte retrieval until the first pregnancy test",[13],"Drug: Ovulation induction with hCG + Luteal phase support with vaginal progesterone",{"label":15,"type":16,"description":17,"interventionNames":18},"Ovulation triggering with Triptorelin + Luteal phase support with Nafarelin","EXPERIMENTAL","Triptorelin 0.2 mg subcutaneously between 36h and 38h before oocyte retrieval as a single dose Nafarelin 400µg \u002Fday (200µg in the morning 200µg in the evening) nasally from the evening of the oocyte retrieval until the first pregnancy test",[19],"Drug: Ovulation triggering by Triptorelin + Luteal phase support by Nafarelin",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ovulation induction with hCG + Luteal phase support with vaginal progesterone","hCG 250µg subcutaneously between 36h and 38h before oocyte retrieval + Progesterone 600mg\u002Fd (200mg morning, noon and evening) vaginally from the evening of the puncture until the pregnancy test result",[9],null,{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"Ovulation triggering by Triptorelin + Luteal phase support by Nafarelin",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Maeliss Peigné, MCU-PH","CONTACT","01 48 02 68 56","maeliss.peigne@aphp.fr",[37],{"facility":38,"status":39,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Maeliss Peigné","RECRUITING","Bondy","France","FR",{"type":44,"coordinates":45},"Point",[46,47],2.48931,48.9018,{"lat":47,"lon":46},[50],{"name":38,"role":33,"phone":51,"phoneExt":26,"email":35},"0148026856",{"type":53,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100527664","phase-3-luteal-phase-support-with-gnrh-agonist-after-gnrh-agonist-triggering-in-ivficsi-cycles-100527664",false,"NCT06150703","Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF\u002FICSI Cycles","Luteal Phase Support With GnRH Agonist Alone After GnRH Agonist Triggering and Fresh Embryo Transfer Compared to the Reference Protocol (hCG Triggering and Progesterone Luteal Support): a Randomised Controlled Trial","SOLOAGO","Inclusion Criteria:\n\n* Patients requiring conventional IVF or IVF with sperm injection (ICSI) from the partner or donor under the conditions of management defined by French law.\n* Patients aged 18 to 39 included\n* First or second attempt at IVF or ICSI for pregnancy\n* BMI \\\u003C 35 kg\u002Fm2\n* Anti-Mullerian hormone (AMH) \\> 1 ng\u002Fml (= 7 pmol\u002FL) and\u002For antral follicle count ≥ 8 within the year prior to inclusion\n* AMH \\\u003C 5 ng\u002Fml and\u002For antral follicle count \\\u003C40 within the year prior to inclusion\n* Treatment with recombinant FSH\n* Antagonist protocol (with pre-treatment or not)\n* Initial dose of recombinant FSH between 75 and 450 IU\n* Signed informed consent\n* Affiliation to the social security system (excluding AME)\n\nExclusion Criteria:\n\n* Patient diagnosed with HIV infection\n* ICSI with sperm from testicular biopsy\n* Pre-implantation diagnosis\n* Hypogonadotropic hypogonadism (amenorrhea or spaniomenorrhea with basal LH \\\u003C1.2 IU\u002FL)\n* History of severe ovarian hyperstimulation syndrome (OHSS)\n* Unoperated hydrosalpinx\n* Intracavitary polyps or myomas deforming the cavity\n* Known hypersensitivity to the investigational drugs and\u002For their excipients (human chorionic gonadotropin, progesterone, nafarelin acetate, GnRH, GnRH analogues, mannitol, sodium chloride, water for injection, glacial acetic acid, Sodium hydroxide and\u002For hydrochloric acid, sorbitol, purified water, benzalkonium chloride, sunflower oil, soybean lecithin, gelatin, glycerol, titanium dioxide (E171), methionine, poloxamer 18, phosphoric acid).\n* Gynaecological bleeding or genital haemorrhage\n* History of epilepsy and\u002For intracranial tumors potentially causing epilepsy\n* Tumours of the hypothalamus or pituitary gland\n* Ovarian enlargement or cysts unrelated to polycystic ovary syndrome\n* Severe adenomyosis requiring a long protocol\n* Carcinoma of the ovary, uterus or breast\n* Active thromboembolic events\n* Severe impairment of liver function\n* Breastfeeding women\n* Patients under court protection, guardianship or curators\n* Current participation in another therapeutic interventional trial on the day of inclusion\n* Patients who do not speak or understand French","FEMALE","18 Years","39 Years",{"count":66,"type":67},652,"ESTIMATED","INTERVENTIONAL",[70],"PHASE3","The development of stimulation protocols for in vitro fertilisation (IVF) has led to a paradox. It has now been established that obtaining a large number of oocytes is a key to success, but that it is also a risk factor for embryo transfer failure after puncture (disruption of endometrial receptivity due to luteal insufficiency) and a risk factor for complications such as ovarian hyperstimulation syndrome (OHSS).",[73,74],"In Vitro Fertilization","ICSI Intracytoplasmic Spermatozoid Injection",[76,77,78,79],"GnRH agonist triggering","GnRH agonist luteal phase support,","pregnancy","live birth","2025-08-22",{"date":82,"type":83},"2025-08-24","ACTUAL",{"date":85,"type":83},"2024-06-27",{"date":87,"type":67},"2027-09-27",{"name":5,"class":6},1]