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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications
• Intervention / Treatment: Drug: 17β-estradiol/dydrogesterone tablets

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiuxiu Jiang, Ph.D; Phone Number: +8613588709941; Email: jiangxiuxiu0418@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Women's Hospital School of Medicine Zhejiang University
      • Contact: Xiuxiu Jiang, Ph.D; Phone Number: +8613588709941; Email: jiangxiuxiu0418@zju.edu.cn
      • Sub-Investigator: Wanren Zheng, MD
      • Sub-Investigator: Juan Yu, MD
      • Sub-Investigator: Meijun Guo, MD
      • Sub-Investigator: Ning Wang, MD
      • Sub-Investigator: Shanshan Ni, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Femoston group; 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; 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.
No Intervention: No Femoston group; The blank control group did not receive Femoston（17β-estradiol/dydrogesterone tablets after induced abortion surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of vaginal bleeding after surgery	number of days of vaginal bleeding after induced abortion surgery	The 21st day after induced abortion surgery
menstrual flow volume	Amount of menstrual flow during the first menstrual cycle after surgery	21st day of the first post-operative menstrual cycle

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Investigators: Principal Investigator: Xiuxiu Jiang, Ph.D, Women's Hospital School of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: estrogen; Intrauterine adhesion; induced abortion; endometrial repair
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Pregnancy Complications; Gynatresia; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Estradiol; Dydrogesterone
• Other Study ID Numbers: PRO2023-3733; BJ2023YCPYJH003 (Other Grant/Funding Number: China Health & Medical Development Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No