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

NCT06546397 | Recruiting Phase 1 DMC

• 2 other identifiers: PRO2023-3733BJ2023YCPYJH003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Complications

Keywords

induced abortion; Intrauterine adhesion; estrogen; endometrial repair

Outcome Measures

Primary Outcomes (2)

• The thickness of the endometrium

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

  The 21st day after induced abortion surgery

• 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

  21st day of the first post-operative menstrual cycle

Secondary Outcomes (2)

• Duration of vaginal bleeding after surgery

  The 21st day after induced abortion surgery

• menstrual flow volume

  21st day of the first post-operative menstrual cycle

Study Arms (2)

Femoston group

EXPERIMENTAL

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).The medication product name is called Femoston。

Drug: 17β-estradiol/dydrogesterone tablets

No Femoston group

NO INTERVENTION

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

Interventions

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.

Femoston group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnancy can happened to female only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications; Gynatresia

Interventions

Estradiol; Dydrogesterone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienes; Pregnanes

Study Officials

• Xiuxiu Jiang, Ph.D

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuxiu Jiang, Ph.D

CONTACT

+8613588709941; jiangxiuxiu0418@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The eligible population who underwent induced abortion were divided into two groups using block randomization. The experimental group received estrogen and progesterone therapy after surgery, while the other group served as a blank control group. Twenty-one days after surgery, a follow-up examination was conducted to assess the recovery of the endometrium and measure the endometrial thickness. Twenty-one days after the first post-operative menstrual cycle, blood samples were taken for laboratory tests to evaluate the recovery of ovarian function.

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: May 9, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 28, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)