CTRI/2016/01/006490进行中（未招募）3 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
试验速览
- 阶段
- 3 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
入排标准
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
- •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 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. Negative pregnancy test on the day of pituitary down regulation (prior
- •to administration of GnRH agonist or GnRH antagonist)
- •9. Clinically indicated protocol for induction of IVF with a fresh embryo
- •10. Single or dual embryo transfer
- •11. BMI >= 18 and <= 30 kg/m2
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 investigators 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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