EUCTR2013-001105-81-BG进行中（未招募）不适用
Randomized Clinical Trial to Compare the Pregnancy Rates of Vaginally Applied Cyclogest® Pessary and Crinone® 8% Gel After In-vitro Fertilization
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 766
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Age (calculated from date of birth) at randomization between 18 and 40 years
- •2. Body mass index = 18 and = 30 kg/m2
- •3. Infertility due to any of the following factors: tubal factor, mild endometriosis (American Society for Reproductive Medicine [ASRM] stage 1 to 2), male factor, unexplained infertility
- •4. Presence of at least one ovary, and uterine cavity without significant abnormalities
- •5. First, second, or third fresh cycle in the present series of assisted reproductive technology (ART)
- •6. = 4 oocytes were retrieved in the current ART cycle
- •7. Serum follicle stimulating hormone (FSH) level = 12 IU/L (on menstrual cycle day 1 to 5) within any menstrual cycle within one year prior to randomization
- •8. ART procedure according to:
- •undergoing routine down-regulation with gonadotropin releasing-hormone (GnRH) agonist or using GnRH antagonist
- •undergoing stimulation regimen with FSH and/or human menopausal gonadotropin (hMG) with total starting dose ranging from 100 IU to 300 IU per day, and a maximum total dose of up to 450 IU per day
- •human chorionic gonadotropin (hCG 5000 or 10000 IU) trigger injection when at least 3 follicles with diameter = 17 mm are observed during TVUS
- •oocyte retrieval (OR) is planned for 35 to 37 hours after hCG trigger injection
- •ET on Day 2 or 3 after OR (1 to 3 embryos depending on number of previous fresh cycles and age of woman according to the site's clinical practice and national legislation if applicable)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 766
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Presence of pregnancy
- •2. More than two previously failed complete ART fresh cycles
- •3. Donor egg recipient
- •4. Any contraindication to being pregnant and/or carrying pregnancy to term
- •5. Presence of any medical condition for which the use of progesterone is contraindicated, (e.g. porphyria, etc.)
- •6. Known postmenopausal status
- •7. Vaginal abnormalities (including untreatable abnormal discharges)
- •8. History of gynecological neoplasia (breast, uterus, ovary, cervix, vagina)
- •9. Presence of clinically significant endometriosis (> 1 cm ovarian endometrioma)
- •10. Uterine fibroids suspected to affect study procedures (assessed by ultrasound or hysteroscopy (HSC) / hysterosalpingogram (HSG))
- •11. Known blood coagulation disorders
- •12.Epilepsy, migraine with neurological symptoms, cardiac or renal dysfunction, cholelithiasis
- •13. History of or current clinically significant depression, at the discretion of the investigator
- •14. Occurrence of severe ovarian hyperstimulation syndrome (OHSS) according to Golan (Grade IV, V or VI)
- •15. Present use or use within 2 months prior to start of the study, medication of the following drugs: phenytoin, phenobarbitone, phenylbutazone, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, rifabutin, nevirapine, efavirenz, nelfinavir, ritonavir, griseofulvin, ketoconazole
- •16. Administration of investigational drugs within 2 months prior to start of study medication
- •17. Known hypersensitivity to one of the study drugs or any of the excipients
研究者
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