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NCT Number: NCT05085067

The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception

Retained product of conception (RPOC) is defined by abnormal trophoblastic persistence or retained placenta inside the uterus cavity after a pregnancy independently of the outcome. Untreated RPOC can compromise future fertility. RPOC are generally treated surgically, either by repeated evacuation or by hysteroscopy, which exposes the uterus to additional potential trauma.The combination of trauma to the gravid uterine cavity, hypoestrogenic state at the time of the operation or immediately afterward and local infection is considered to be the pathogenic mechanism of intrauterine adhesions (IUA) , manifested clinically by menstrual abnormalities, infertility and recurrent pregnancy loss.To investigate the efficacy of auto-cross linked hyaluronic acid gel in the prevention of adhesion reformation after hysteroscopic resection of retained products of conception.

After the completion of hysteroscopic resection of retained products of conception, patients will be randomized to one of the two groups by computer-generated numbers: [1] infusing auto-cross linked hyaluronic acid gel into intrauterine cavity in the experimental group; [2] no auto-cross linked hyaluronic acid gel into intrauterine cavity in the control group. Second and third look outpatient hysteroscopy will be performed 4 and 8 weeks after the initial surgery. The patients will be followed up about menstrual pattern at 3 months after the surgery.The patients will be followed up about pregancy outcome at 12 months after the surgery.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of retained products of conception
  • Written consent obtained

Exclusion criteria

  • Patients with severe complications of medicine and surgery
  • Acute or chronic genital tract inflammation
  • No understanding or approving the randomized controlled trial

Treatment and study plan

auto-crossed-linked hyaluronic acid gel

Other

infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception

Primary outcomes

  1. Adhesion reformation rate at third-look hysteroscopy

    Time frame: A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.

  2. Adhesion score at third-look hysteroscopy

    Time frame: A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.

  3. Concentration of the menstrual pattern

    Time frame: at 3 months after the initial surgery

  4. Pregnancy rate

    Time frame: at 12-month after the initial surgery

Secondary outcomes

  1. Rate of complications

    Time frame: up to 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Rong Li Huo, Doctor

CONTACT

[email protected]

8601088062032

Xue Yang, Master

CONTACT

[email protected]

8618810957056

Sponsors and collaborators

Lead sponsor

Fu Xing Hospital, Capital Medical University

Other

Registry information

Official study title

The Efficacy of Auto-crosslinked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception:a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 20, 2021
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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