NCT00827983已完成3 期
Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel 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
- 683
- 试验地点
- 14
- 主要终点
- Ongoing Pregnancy Rate at the End of the Study
研究概览
简要总结
Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).
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
- •Age 18- 42 (upon starting COH);
- •BMI <30 kg/m2;
- •<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 polyp or protruding sub-mucosal fibroid);
- •At least 3 retrieved oocytes;
- •Patient has given written informed consent.
排除标准
- •Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
- •Stage III or IV endometriosis (endometriomas);
- •Hydrosalpinx;
- •History of past poor response to COH resulting in canceling ART;
- •Use of thawed/donated oocytes;
- •Use of thawed/donated embryos;
- •Patients affected by pathologies associated with any contraindication of being pregnant;
- •Hypersensitivity to study medication;
- •Uncontrolled adrenal or thyroid dysfunction;
- •Undiagnosed vaginal bleeding;
- •History of arterial disease;
- •Patients with hepatic impairment;
- •Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
- •High grade cervical dysplasia;
- •Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
- •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 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 Vaginal gel
Active Comparator
干预措施: Progesterone (Drug)
结局指标
主要结局
Ongoing Pregnancy Rate at the End of the Study
时间窗: 10 weeks after treatment start
次要结局
- Delivery Rate and Live Birth Rate(nearly 9 month after treatment start)
- Implantation Rate(Four to five weeks after oocytes retrieval)
研究者
研究点 (14)
Loading locations...
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