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NCT Number: NCT06546397

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

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.

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Key information

Conditions

Pregnancy Complications Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

17β-estradiol/dydrogesterone tablets

Drug

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.

Primary outcomes

  1. The thickness of the endometrium

    Time frame: The 21st day after induced abortion surgery

    Measurement of endometrial thickness by B-ultrasound on the 21st day after induced abortion surgery

  2. Cycle normalization rate

    Time frame: 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

Secondary outcomes

  1. Duration of vaginal bleeding after surgery

    Time frame: The 21st day after induced abortion surgery

    number of days of vaginal bleeding after induced abortion surgery

  2. menstrual flow volume

    Time frame: 21st day of the first post-operative menstrual cycle

    Amount of menstrual flow during the first menstrual cycle after surgery

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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