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Идёт набор NCT06546397

Study on the Effect of Combined Estrogen and Progestogen Therapy on Endometrial Repair After Induced Abortion

Фаза I С лечением Pregnancy Complications

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 17β-estradiol/dydrogesterone tablets.
Кому может быть актуально
Состояния в реестре: Pregnancy Complications. Базовые параметры: 18 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Prospective Cohort Study on the Effect of Combined Estrogen and Progestogen Therapy on Endometrial Repair and Ovarian Function Recovery After Induced Abortion

Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат 17β-estradiol/dydrogesterone tablets
    The medication group began taking 17β-estradiol/dydrogesterone tablets orally for 28 days starting from the first day after induced abortion surgery (taking 2mg of 17β-estradiol orally once a day for the first 14 days, and then taking 2mg of 17β-estradiol + 10mg of dydrogesterone tablets orally once a day for the next 14 days). The blank control group did not take any medication.

Первичные конечные точки

  • The thickness of the endometrium [Срок оценки: The 21st day after induced abortion surgery]
  • Cycle normalization rate [Срок оценки: 21st day of the first post-operative menstrual cycle]
Вторичные конечные точки (2)
  • Duration of vaginal bleeding after surgery [Срок оценки: The 21st day after induced abortion surgery]
  • menstrual flow volume [Срок оценки: 21st day of the first post-operative menstrual cycle]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Women's Hospital School Of Medicine Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT06546397 · PRO2023-3733 · BJ2023YCPYJH003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗