Effectiveness of Progesterone Supplementation for Women Having Low Progesterone Levels on the Day of Frozen Embryo Transfer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 824
- 试验地点
- 2
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
The main objective of this study is to compare clinical pregnancy rates between two groups of women who have progesterone levels below 10 ng/mL on the day of frozen embryo transfer: group 1 (vaginal micronized progesterone supplemented with progesterone intramuscular 50 mg per day) and group 2 (vaginal micronized progesterone with no supplementation)
详细描述
Trial Design:
Single center, longitudinal, randomized, interventional, controlled, pharmacological study, enrolling women attending clinical Centers of medically assisted reproduction (ART).
The study protocol consists in the record of all the diagnostic and clinical outcome parameters, according to clinical practice, for the following patient cohorts:
-
The patients who are undergoing frozen embryo transfers with blastocyst or cleavage stage embryos and have progesterone levels below 10 ng/mL on the day of embryo transfer
-
Study groups
-
Group supplemented with progesterone intramuscular 50 mg per day until the day of beta-hcg testing (Intervention group);
-
Group with no supplementation (Control group).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients undergone ART with frozen embryo transfer, blastocyst or cleavaged stage embryo transfer, from 18-45 years of age
- •Normal BMI
- •HRT for Endometrial preparation in FET cycles
排除标准
- •Oocyte donor cycles
- •Surrogacy
- •Abnormal Uterine (firbroids 0 -> 3 according to FIGO classification, polyp, adenomyosis, congenital malformation)
- •Uterus fibroids type 4,5 (Figo classification) > 4cm
- •History of recurrent implantation failure
- •Endometrial thickness <7mm on the day of ET
- •Cesarean scar defect (isthmocele)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: week 11 - 14 of pregnancy
defined as the pregnancy completed 11 - 14 weeks of gestation and having vital fetus
次要结局
- implantation rate(3 weeks after embryo transfer)
- Pregnancy rate(2 weeks after embryo transfer)
- clinical pregnancy rate(3 weeks after embryo transfer)
研究者
Le Thi Minh Chau
MD, MMSc, PhD, Head of Infertility department of Tu Du hospital
Tu Du Hospital