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临床试验/NCT06644794
NCT06644794尚未招募3 期

Comparison of Progesterone-modified Natural Cycle and Hormone Replacement Therapy Cycle for Endometrial Preparation in Single Frozen Blastocyst Transfer

Shandong University of Traditional Chinese Medicine0 个研究点目标入组 336 人开始时间: 2024年12月5日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
尚未招募
入组人数
336
主要终点
Live birth

研究概览

简要总结

Hormone replacement therapy (HRT) cycles, despite the ease of synchronizing embryo thawing and embryo transfer timing, increase the risk of pregnancies and obstetric complications compared to natural cycles (NC). By ensuring the presence of the corpus luteum while reducing the number of monitoring sessions, the progesterone modified natural cycle (P4mNC) offers more convenience for the patient than the normal NC. This study is designed to compare the effects of P4mNC and HRT cycles on FET outcomes.

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
21 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged 21 to 44 years undergoing FBT
  • Body mass index (BMI) 18-35 kg/m2
  • Having regular ovulatory cycles

排除标准

  • Untreated uterine adhesions
  • Medical contraindications to estrogen and progesterone therapy
  • Illnesses contraindicating assisted reproductive technology or pregnancy
  • History of recurrent implantation failures (> 2 embryo transfer failures)

研究组 & 干预措施

P4mNC group

Experimental

On days 8-12 of the menstrual cycle (MC), depending on the length of the patient's MC, transvaginal ultrasound is used to monitor follicular development and endometrial growth. Vaginal micronized progesterone (Utrogestan, Besins, Belgium) is started at 200 mg in the afternoon and 200 mg in the evening when the dominant follicle reached ≥16 mm and the endometrial thickness is at least 7 mm. A blastocyst is transferred on day 5 after the addition of progesterone. On day 14 after blastocyst transfer, serum β-hCG levels are measured. Upon positive serum pregnancy testing, progesterone support will continue until 8-10 weeks of gestation. However, afternoon progesterone use is eliminated for 30 days after embryo transfer.

干预措施: Progesterone-modified natural cycle preparation for frozen embryo transfer (Drug)

HRT group

Active Comparator

Endometrial preparation will begin on the second day of the menstrual cycle with oral estradiol (E2) valerate at a dose of 2 mg twice daily. When the patient's endometrial thickness is ≥7 mm, vaginal progesterone administration will be initiated at a dose of 200 mg 3 times daily. On day 5 of the progesterone administration, blastocysts are thawed and transferred. For patients with endometrial thickness <7 mm, patients continued oral E2 until the endometrium is ≥7 mm. On day 14 after blastocyst transfer, serum β-hCG levels are measured. Upon positive serum pregnancy testing, E2 and progesterone supplementation is continued for 8-10 weeks of gestation.

干预措施: Hormone replacement therapy cycle preparation for frozen embryo transfer (Drug)

结局指标

主要结局

Live birth

时间窗: Within 1 year after randomization

A live birth is defined as the delivery of any surviving newborn at 28 weeks or more of gestation.

次要结局

  • Biochemical pregnancy(Two weeks after embryo transfer)
  • Clinical pregnancy(Five weeks after embryo transfer)
  • Ongoing pregnancy(Ten weeks after embryo transfer)
  • Miscarriage(Within 28 weeks of pregnancy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing-Yan Song

Prof.

Shandong University of Traditional Chinese Medicine

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