Multi-center, Parallel-group, Randomized Controlled Trial of Modified Natural Versus Programmed Cycles for Frozen Embryo Transfers and Their Association With Preeclampsia and Live Births
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 788
- 试验地点
- 30
- 主要终点
- Preeclampsia
研究概览
简要总结
NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing frozen embryo transfer (FET) will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent).
详细描述
NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing FET will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent). The study will implement a stratified randomization design to balance the use of pre-implantation genetic testing (PGT) across the two treatment arms. Each participant will have up to 3 FET cycles until live birth occurs, or the participant has no embryos available for transfer. Primary endpoints will be the proportion of women experiencing preeclampsia comparing modified natural to programmed FET among women with viable pregnancy (defined as pregnancy lasting at least 20 weeks) and the cumulative proportion of women having live births in the two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •To be eligible, subjects must meet all these criteria:
- •Age 18-39 years at the time that embryos were created if no PGT testing was performed. If PGT testing was performed and indicates that an embryo is euploid, the patient can be included if she was age 18-41 years at the time that the embryo was created.
- •Age 18-41 years at the time of randomization as advancing age itself becomes a significant risk for preeclampsia
- •Normal uterine cavity as assessed by saline infusion sonohysterogram, hysterosalpingogram, or hysteroscopy within one year of the enrollment visit, and repeated at the discretion of the investigator
- •Regular menstrual cycle length (approximately 24-35 days) indicative of ovulatory cycles.
- •Willing to undergo elective single embryo transfer
- •Body Mass Index <=40
- •If Body Mass Index is over 30 or individual has other risk factors for diabetes, normal hemoglobin A1C
- •Prior to enrollment, participant will have at least one vitrified blastocyst with euploid result by pre-implantation genetic testing (PGT-A) or at least one vitrified blastocyst of fair or better morphologic quality if no PGT-A results are available.
- •Willingness to be randomized to either a modified natural or programmed cycle, with a willingness to administer intramuscular progesterone in oil if assigned to the programmed cycle.
- •Normal thyroid stimulating hormone (TSH), according to local laboratory standards (or TSH level with a clinically insignificant abnormality per the site director), within one year of study enrollment and repeated at the discretion of the investigator. Use of thyroid medication is permitted.
排除标准
- •To be eligible, subjects must not meet any one of these criteria:
- •Medical contraindication to pregnancy
- •Embryos created using donor oocytes
- •Embryo donation
- •Gestational carrier
- •Reciprocal IVF (one female partner carrying pregnancy, other female partner as source of eggs)
- •Fresh embryos created from frozen oocytes. Patients with frozen embryos created from frozen oocytes can be included.
- •Recurrent implantation failure defined as no clinical pregnancy with ≥ 2 prior consecutive embryo transfers unless patient also had successful live birth between or after the failed embryo transfers
- •Anti-phospholipid antibody syndrome or rheumatologic disease requiring chronic systemic medications
- •Uncontrolled diabetes mellitus
- •History of >1 pregnancy loss in the second or third trimester
- •Uncontrolled hypertension
- •Untreated hydrosalpinx (i.e., hydrosalpinx in situ which has not been ligated or removed)
- •Mullerian uterine anomaly, if not correctable
- •Physician recommendation to perform the embryo transfer outside of the timing specified by the protocol
- •Contraindication to any medication which must be used in preparation for the frozen embryo transfer (i.e., estradiol, progesterone, hCG)
结局指标
主要结局
Preeclampsia
时间窗: During pregnancy through the post-partum period, according to ACOG guidelines (typically between 20 weeks gestation and 6 weeks post-delivery)
Frequency of preeclampsia, as defined by American College of Obstetricians and Gynecologists (ACOG) guidelines for hypertensive disorders in pregnancy (Obstetrics \& Gynecology 2020;135:e237-e260)
次要结局
未报告次要终点