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Pregnancy ComplicationsPhase 1NCT06546397

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

A Phase 1 study testing 17β-estradiol/dydrogesterone tablets in people with Pregnancy Complications, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Pregnancy Complications
What is being tested?
17β-estradiol/dydrogesterone tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
9 May 2024to 31 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Xiuxiu Jiang, Ph.D contact

+8613588709941

jiangxiuxiu0418@zju.edu.cn

China1 site, 1 recruiting

  • Women's Hospital School Of Medicine Zhejiang University

    Hangzhou, Zhejiang, 310006

    Xiuxiu Jiang, Ph.D, +8613588709941, jiangxiuxiu0418@zju.edu.cn

    Wanren Zheng, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
17β-estradiol/dydrogesterone tablets
Keywords
induced abortion, Intrauterine adhesion, estrogen, endometrial repair
Medical subject headings
Pregnancy Complications, Gynatresia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 17β-estradiol/dydrogesterone tabletsDrug

    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.

Study groups in NCT06546397
Study groupRoleWhat they receive
Femoston groupExperimentalStarting 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。
Receives: Drug: 17β-estradiol/dydrogesterone tablets
No Femoston groupNo interventionThe blank control group did not receive Femoston（17β-estradiol/dydrogesterone tablets after induced abortion surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The thickness of the endometrium

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

    Measured: 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

    Measured: 21st day of the first post-operative menstrual cycle

Secondary outcomes (2)

  1. Duration of vaginal bleeding after surgery

    number of days of vaginal bleeding after induced abortion surgery

    Measured: The 21st day after induced abortion surgery

  2. menstrual flow volume

    Amount of menstrual flow during the first menstrual cycle after surgery

    Measured: 21st day of the first post-operative menstrual cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start9 May 2024
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06546397
Sponsor's protocol ID
PRO2023-3733
Other IDs
BJ2023YCPYJH003
Status last verified
Aug 2024
First submitted
6 Aug 2024
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 17β-estradiol/dydrogesterone tablets in people with Pregnancy Complications, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiuxiu Jiang, Ph.D (+8613588709941, jiangxiuxiu0418@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The thickness of the endometrium (time frame: The 21st day after induced abortion surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06546397.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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