A Phase III Randomized Controlled Trial Comparing the Efficacy, Safety and Tolerability of Two Formulations of Vaginal Micronized Progesterone
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Infertility
- 发起方
- Fundación Santiago Dexeus Font
- 入组人数
- 1020
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
- 状态
- 招募中
- 最后更新
- 上个月
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
研究者
Unidad Soporte Investigación
Scientific
Santiago Dexeus Font Fundacio Privada
入排标准
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
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)