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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Femoston groupExperimental treatment 1 intervention
Group B: No Femoston groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The thickness of the endometrium

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

Time frame
The 21st day after induced abortion surgery
2

Cycle normalization rate

proportion of ovarian function recovery; blood sampling for estradiol and progesterone level check on the 21st day of the first post-operative menstrual cycle

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

Secondary outcomes

1

Duration of vaginal bleeding after surgery

number of days of vaginal bleeding after induced abortion surgery

Time frame
The 21st day after induced abortion surgery
2

menstrual flow volume

Amount of menstrual flow during the first menstrual cycle after surgery

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

Other outcomes

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