Effect of combined estrogen and progestogen therapy on endometrial repair after abortion
Prospective Cohort Study on the Effect of Combined Estrogen and Progestogen Therapy on Endometrial Repair and Ovarian Function Recovery After Induced Abortion
This study is testing if a combination of estrogen and progesterone can help women recover better from the endometrium after having an abortion.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06546397 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of combined estrogen and progesterone therapy on the repair of the endometrium following induced abortion. It aims to address the complications that may arise from repeated abortions, such as intrauterine adhesions and infertility. The research will evaluate the efficacy and safety of estradiol and dydrogesterone in promoting endometrial recovery and restoring ovarian function. Participants will be monitored through regular follow-ups to assess the outcomes of the treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 40 who have experienced at least two abortions and are within the specified BMI range.
Not a fit: Patients with contraindications to estrogen and progesterone therapy or a history of uterine adhesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve endometrial repair and fertility outcomes for women who have undergone induced abortions.
How similar studies have performed: While there is ongoing debate regarding endometrial repair methods, this approach has not been extensively tested in prior studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- Women's Hospital School Of Medicine Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Xiuxiu Jiang, Ph.D — Women's Hospital School Of Medicine Zhejiang University
- Study coordinator: Xiuxiu Jiang, Ph.D
- Email: jiangxiuxiu0418@zju.edu.cn
- Phone: +8613588709941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.