Prospective Cohort Study on the Effect of Combined Estrogen and Progestogen Therapy on Endometrial Repair and Ovarian Function Recovery After Induced Abortion
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The thickness of the endometrium
研究概览
简要总结
Induced abortion is a common method to terminate pregnancy, but during the operation, it is necessary to dilate the cervix and aspirate the uterine cavity. Repeated induced abortions may increase the risk of uterine damage, leading to cervical stenosis or intrauterine adhesions, thinning of the endometrium, which may affect the implantation of fertilized eggs and the development of embryos, and ultimately may lead to infertility or miscarriage. This study aims to explore the effects of combined estrogen and progesterone on endometrial repair and ovarian function recovery after induced abortion.
详细描述
Postoperative care after induced abortion should prioritize the issue of endometrial repair. In 2021, the Family Planning Branch of the Chinese Medical Association published the "Expert Consensus on Promoting Endometrial Repair After Induced Abortion" [10], emphasizing the importance of endometrial repair for high-risk populations following induced abortion. Currently, clinically, methods to promote endometrial repair include estrogen-progestin medications, compound short-acting oral contraceptives, traditional Chinese medicine, and bioelectric stimulation. However, controversies still exist regarding endometrial repair, and selecting an effective and safe treatment plan remains crucial. This study aims to prospectively evaluate the efficacy and safety of estradiol/estradiol/dydrogesterone in endometrial repair after induced abortion through clinical research, providing a basis for endometrial repair and ovarian function recovery post-abortion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years old (inclusive) and 40 years old (inclusive)
- •Body Mass Index (BMI) ranging from 18.5Kg/㎡ to 23.9Kg/㎡
- •Experienced at least 2 abortions or had a missed abortion
- •Confirmed gestational age of no more than 10 weeks, and the ultrasonic examination within three days prior to the surgery shows a gestational sac (average of three diameters) of at least 1.0cm, with an embryo length of no more than 3.0cm
- •Normal preoperative examination results as per the "Clinical Diagnosis and Treatment Guidelines and Technical Operation Standards: Family Planning Volume (2017 Revision)"
- •Capable of regular follow-ups and willing to sign the informed consent form.
排除标准
- •Individuals with contraindications to estrogen and progesterone therapy
- •History of uterine adhesions confirmed by hysteroscopy, or a history of uterine cavity surgery or uterine malformation correction
- •Subjects who require placement of an intrauterine device or administration of oral contraceptives or subcutaneous implants after the procedure
- •Individuals with mental status or cognitive function abnormalities who are unable to cooperate with the treatment process
- •Subjects who, in the opinion of the investigator, have potential risks or any other factors that may interfere with the study.
研究组 & 干预措施
Femoston group
Starting from the day of the induced abortion surgery, take 17β-estradiol/dydrogesterone tablets orally for 28 days (take 2mg of 17β-estradiol orally once a day for the first 14 days, and then take 2mg of 17β-estradiol + 10mg of dydrogesterone tablets orally once a day for the next 14 days).The medication product name is called Femoston。
干预措施: 17β-estradiol/dydrogesterone tablets (Drug)
结局指标
主要结局
The thickness of the endometrium
时间窗: The 21st day after induced abortion surgery
Measurement of endometrial thickness by B-ultrasound on the 21st day after induced abortion surgery
Cycle normalization rate
时间窗: 21st day of the first post-operative menstrual cycle
proportion of ovarian function recovery; blood sampling for estradiol and progesterone level check on the 21st day of the first post-operative menstrual cycle
次要结局
- Duration of vaginal bleeding after surgery(The 21st day after induced abortion surgery)
- menstrual flow volume(21st day of the first post-operative menstrual cycle)