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

Women's Hospital School Of Medicine Zhejiang University

Status and phase: Enrolling; Phase 1

Conditions: Pregnancy Complications

Treatments: Drug: 17β-estradiol/dydrogesterone tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT06546397

BJ2023YCPYJH003 (Other Grant/Funding Number)

PRO2023-3733

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Age between 18 years old (inclusive) and 40 years old (inclusive); 2. Body Mass Index (BMI) ranging from 18.5Kg/㎡ to 23.9Kg/㎡; 3. Experienced at least 2 abortions or had a missed abortion; 4. 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; 5. Normal preoperative examination results as per the "Clinical Diagnosis and Treatment Guidelines and Technical Operation Standards: Family Planning Volume (2017 Revision)"; 6. Capable of regular follow-ups and willing to sign the informed consent form.

Exclusion criteria

• 1. Individuals with contraindications to estrogen and progesterone therapy; 2. History of uterine adhesions confirmed by hysteroscopy, or a history of uterine cavity surgery or uterine malformation correction; 3. Subjects who require placement of an intrauterine device or administration of oral contraceptives or subcutaneous implants after the procedure; 4. Individuals with mental status or cognitive function abnormalities who are unable to cooperate with the treatment process; 5. Subjects who, in the opinion of the investigator, have potential risks or any other factors that may interfere with the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

200 participants in 2 patient groups

medication group

Experimental group

Description:

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).

Treatment:

Drug: 17β-estradiol/dydrogesterone tablets

Blank group

No Intervention group

Description:

The blank control group did not receive 17β-estradiol/dydrogesterone tablets after induced abortion surgery.