NCT00828191已完成3 期
Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone for Luteal Phase Support in Patients Undergoing In Vitro Fertilization (IVF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 8
- 主要终点
- Ongoing Pregnancy Rate
研究概览
简要总结
Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient has given written informed consent;
- •BMI < 30 kg/m2;
- •Age 18 - 42 (upon starting COH);
- •<3 prior ART cycles (IVF, ICSI and related procedures);
- •Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
- •Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or hysteroscopic exam (i.e. no polyps or protruding submucosal fibroids);
- •Patients must have at least three retrieved oocytes.
排除标准
- •Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
- •Stage III or IV endometriosis (no endometriomas);
- •Hydrosalpinges;
- •History of past poor response to COH resulting in canceling ART;
- •Use of thawed/donated oocytes;
- •Use of thawed/donated embryos;
- •Gestational carrier;
- •Patients affected by pathologies associated with any contraindication of being pregnant;
- •Hypersensitivity to study medication;
- •Uncontrolled adrenal or thyroid dysfunction;
- •History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product;
- •History of arterial disease;
- •Patients with hepatic impairment (liver function tests > 2x upper limits of normal);
- •Patients with dermatologic disease;
- •Patients with renal impairment (estimated creatinine clearance <60 mL/min/1.73 m2);
- •Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
- •High grade cervical dysplasia;
- •History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages, wherein pregnancy developed to a minimum of a gestational sac on TVUS;
- •Participation in a concurrent clinical trial or in another trial within the past 2 months;
- •Use of concomitant medications that might interfere with the study evaluation;
- •Pre-implantation genetic diagnosis/screening
研究组 & 干预措施
Progesterone SC
Experimental
干预措施: Progesterone (Drug)
Progesterone Tablets
Active Comparator
干预措施: Progesterone (Drug)
结局指标
主要结局
Ongoing Pregnancy Rate
时间窗: 10 weeks after treatment start
次要结局
- Implantation Rate(4-5 weeks after treatment start)
- Delivery Rate(nearly 9 months after treatment start)
研究者
研究点 (8)
Loading locations...
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