RecruitingPhase 1NCT06546397

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

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

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Enrollment

200 participants

Start Date

May 9, 2024

Study Type

INTERVENTIONAL

Conditions

Pregnancy Complications

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria6

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 Criteria5

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.

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Interventions

DRUG17β-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.