A Phase III Randomized Controlled Trial Comparing the Efficacy, Safety and Tolerability of Two Formulations of Vaginal Micronized Progesterone
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,020
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
This randomized trial was designed as non-inferiority trial aiming to compare ongoing pregnancy rates following LPS with 600 mg/day vs 800 mg/day vaginal VMP. All patients will undergo an artificial cycle frozen embryo transfer (AC-FET) with transdermal estradiol 6mg/day Patients undergoing an artificial cycle FET will start estrogen priming with transdermal estradiol 6mg/day (Estrogel®) on cycle D1-D3. Following 10-12 days of estrogen priming, patients will be randomized to luteal phase support with a standard formulation (200mg tid, Utrogestan®) or a new formulation (400mg bid) VMP. All patients will undergo a serum P measurement on the day before embryo transfer (ET). Patients with P<10 ng/ml will receive a supplement of oral micronized progesterone 300mg, while patients with P≥10ng/ml will maintain the previous luteal phase support (LPS) protocol
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Endometrial preparation with hormone replacement therapy
- •Age 18-43 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy)
- •Age < 50 years following an egg donation cycle
- •BMI > 18 and < 30 kg/m2
- •blastocyst embryo transfer
- •Willing to participate in the study
- •Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation.
- •Exlusion Criteria:
- •• Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities)
- •Hydrosalpinx
- •Recurrent pregnancy loss (≥ 3 previous miscarriages)
- •Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts)
- •Allergy to study medication
- •Pregnancy or lactation
- •Contraindication for hormonal treatment
- •Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test
- •Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment).
排除标准
- •Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities)
- •Hydrosalpinx
- •Recurrent pregnancy loss (≥ 3 previous miscarriages)
- •Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts)
- •Allergy to study medication
- •pregnancy or lactation
- •Contraindication for hormonal treatment
- •Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test
- •Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment).
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 7-9 weeks after embryo transfer
A positive heart beat at ultrasound after 11-13 weeks of gestation
次要结局
- Frequency of adverse events(Until 15 days after the end of treatment with progesterone)
- Implantation rate(3-4 weeks after embryo transfer)
- Biochemical pregnancy rate(10 to 12 days after embryo transfer)
- Clinical pregnancy rate(3-4 weeks after embryo transfer)
- Miscarriage rate(before completion of 12 weeks of gestation)
研究者
Unidad Soporte Investigación
Scientific
Santiago Dexeus Font Fundacio Privada