Correlation Between Endometrial Peristalsis And Pregnancy Outcomes In Patients Undergoing Frozen Embryo Transfer With Hormone Replacement Therapy for Endometrial Preparation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- The association between endometrial peristalsis at different time points and live birth rates
研究概览
简要总结
Endometrial peristalsis may influence embryo implantation and pregnancy outcomes, but its role during hormone replacement therapy (HRT)-prepared frozen embryo transfer (FET) cycles remains unclear. This prospective observational study will assess endometrial peristalsis at predefined time points during HRT-prepared FET cycles using transvaginal ultrasonography and evaluate its association with pregnancy outcomes. The study aims to clarify the clinical significance of endometrial peristalsis in HRT-prepared FET cycles and to provide evidence supporting endometrial assessment in assisted reproductive technology.
详细描述
Frozen embryo transfer (FET) has become an integral component of assisted reproductive technology (ART), and successful implantation depends on adequate endometrial receptivity. Different endometrial preparation protocols, including natural cycles and hormone replacement therapy (HRT) cycles, create distinct hormonal environments that may influence endometrial physiology. Among these protocols, HRT is the most widely used approach because it is applicable to a broad range of patients and offers greater flexibility in treatment scheduling.
Endometrial peristalsis, characterized by rhythmic contractions of the uterine junctional zone, is thought to play an important role in embryo transport and implantation. Previous studies have suggested that the frequency and direction of endometrial peristalsis are influenced by ovarian steroid hormones and may be associated with implantation and pregnancy outcomes. However, most available evidence has focused on natural menstrual cycles, while data regarding endometrial peristalsis during HRT-prepared FET cycles remain limited and inconsistent. The temporal changes in endometrial peristalsis throughout HRT endometrial preparation and their relationship with reproductive outcomes have not been fully elucidated.
This prospective observational study is designed to characterize endometrial peristalsis during HRT-prepared FET cycles using transvaginal ultrasonography and to evaluate the association between endometrial peristalsis and pregnancy outcomes. Endometrial peristalsis will be assessed at predefined time points during endometrial preparation, and pregnancy outcomes will be compared according to the observed peristaltic patterns. The results of this study are expected to improve understanding of endometrial physiology during HRT-prepared FET cycles and provide evidence on the clinical significance of endometrial peristalsis for reproductive outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 - 42 years old
- •Scheduled for frozen embryo transfer cycles using hormone replacement therapy protocol
- •Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts
- •Provision of written informed consent to participate
排除标准
- •Having an allergy and contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease)
- •Cycles with preimplantation genetic testing, oocyte donation, or in vitro maturation
- •Having untreated uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus, endometrial polyp, large leiomyoma ≥5 cm in diameter, hydrosalpinx, endometrial hyperplasia)
- •Use of uterine relaxants or intralipid infusion during the embryo transfer process
- •Use of a GnRH-agonist for downregulation within one month
研究组 & 干预措施
Exogenous steroid protocol
The endometrium will be prepared with the use of oral estradiol valerate (Progynova®; Delpharm Lille SAS, France, or Valiera®, Laboratorios Recalcine) at a dose of 6 mg per day, starting on the second, third, or fourth day of the menstrual cycle. Endometrial thickness will be monitored from day 10 onward, and vaginal progesterone (Cyclogest, LD Collins, UK) at 800 mg per day and dydrogesterone (Duphaston, Abbott Biologicals B.V, US) at 20 mg per day will be started when the endometrial thickness reaches 8 mm or more. Embryo transfer was performed at 4 days for cleavage embryo transfer or at 6 days for blastocyst embryo transfer, after progesterone was started. All embryos were warmed on the day of transfer. Vaginal progesterone administration will be maintained until the day of the pregnancy test. In the event of a positive test result, luteal phase support will be extended until 10 weeks of gestation.
干预措施: Endometrial peristalsis and hormone measurements (Other)
结局指标
主要结局
The association between endometrial peristalsis at different time points and live birth rates
时间窗: Up to delivery
The association between endometrial peristalsis at different time points and live birth rates
The correlation between endometrial peristalsis at different time points and live birth rates
时间窗: Up to delivery
The correlation between endometrial peristalsis at different time points and live birth rates
次要结局
- The frequency of endometrial peristalsis at different time points(• On the second day to the fourth day of the menstrual cycle in the FET cycles. • The day of progesterone initiation (before progesterone exposure) • On the day of embryo transfer, immediately prior to the procedure)
- The correlation between endometrial peristalsis at different time points(• On the second day to the fourth day of the menstrual cycle in the FET cycles. • The day of progesterone initiation (before progesterone exposure) • On the day of embryo transfer, immediately prior to the procedure)
- Direction of peristalsis(• On the second day to the fourth day of the menstrual cycle in the FET cycles • The day of progesterone initiation (before progesterone exposure) • On the day of embryo transfer, immediately prior to the procedure)
- The association between endometrial peristalsis at different time points and pregnancy rates(Up to delivery)
- Live birth rates after the one embryo transfer(At delivery)
- Positive pregnancy test(10-14 days after embryo transfer)
- Clinical pregnancy(4-6 weeks after embryo transfer)
- Ongoing pregnancy(12 weeks of gestation or beyond)
- Implantation rate(At 4-6 weeks after embryo transfer)
- Ectopic pregnancy(Up to 12 weeks after embryo transfer)
- Miscarriage(Up to 22 weeks of gestation)
- Multiple gestations(At delivery)
- Multiple birth(At delivery])
- Mode of delivery(At delivery)
- Birth weight(At delivery)
- Gestational age at birth(At delivery)
- Preterm birth(At delivery)
- Gestational diabetes mellitus(At 24-28 weeks of gestation)
- Hypertensive disorders of pregnancy(Up to delivery)
- Stillbirth(Up to delivery)
- Very low birth weight(Up to delivery)
- Low birth weight(Up to delivery)
- High birth weight(Up to delivery)
- Very high birth weight(Up to delivery])
- Major congenital abnormalities(Up to delivery)
- NICU admission(Up to delivery)
- Neonatal mortality(Up to delivery)