EUCTR2007-006595-11-HU进行中（未招募）不适用
Efficacy and Tolerability of Subcutaneous Progesterone (IBSA)versus Vaginal Progesterone Gel (Crinone®) for Luteal Phase Supportin Patients Undergoing In-Vitro Fertilization (IVF).
IBSA Institute Biochimique SA0 个研究点目标入组 672 人开始时间: 2008年7月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 672
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
- •- 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,
- •sonohystogram or hysteroscopic exam (i.e. no polyp or protruding
- •sub-mucosal fibroid);
- •- At least 3 retrieved oocytes;
- •- Patient has given written informed consent.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Intramural uterine fibroids that distort the uterine cavity or polyps >1
- •- 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;
- •- 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.
研究者
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