EUCTR2012-002993-29-BE进行中（未招募）1 期
A Randomized, Open-label, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg daily versus Crinone 8% intravaginal progesterone gel 90 mg daily for Luteal Support in In-Vitro Fertilization (LOTUS II) - LOTUS II
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,066
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.Signed informed consent
- •2.Premenopausal females, age > 18 years < 42 years
- •3.Non-smokers. For females who were past smokers, they must have stopped tobacco usage for at least 3 months prior baseline visit
- •4.Early follicular phase (Day 2-4) FSH (Follicle stimulating hormone) less than or equal to 15 IU/L and estradiol (E2)within normal limits at screening
- •5.LH (luteinizing hormone), PRL (prolactin), T (testosterone) and TSH (thyroid-stimulating hormone), within the normal limits for the clinical laboratory, or considered not clinically significant by the Investigator within 6 months prior to or at screening
- •6.Documented history of infertility (e.g., unable to conceive for at least one year or for 6 months for women = 38 years of age or bilateral tubal occlusion or absence)
- •7.Normal transvaginal ultrasound at screening (or within 14 days of screening) without evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa (no hydrosalpinx or clinically relevant uterine fibroids)
- •8.Subject is not pregnant either confirmed by negative pregnancy test or by of investigator judgement
- •9.Clinical indicated protocol for induction of IVF with a fresh embryo
- •10.Single or dual embryo transfer
- •11.BMI =18 and = 30 kg/m2
- •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 1066
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery (< 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which could limit participation in or completion of the study;
- •2.Acute urogenital disease
- •3.Known allergic reactions to progesterone products
- •4.Intake of experimental drug or any participation in any other clinical trial within 30 days prior to study start
- •5.Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects in or to complete the study
- •6.Current or recent substance abuse, including alcohol and tobacco (Note: Patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed)
- •7.History of chemotherapy
- •8.Patients with more than 3 unsuccessful IVF attempts
- •9.Contraindication for pregnancy
- •10.Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests
- •11.History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
研究者
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