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

• Sponsor: Fu Xing Hospital, Capital Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05085067
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 33.7
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Retained Products of Conception	Other: auto-crossed-linked hyaluronic acid gel	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Jan 21, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Group A: no auto-cross linked hyaluronic acid gel no auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception
Experimental: Group B: infusing auto-cross linked hyaluronic acid gel infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception	Other: auto-crossed-linked hyaluronic acid gel; infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception

Outcome Measures

Primary Outcome Measures

1. Adhesion reformation rate at third-look hysteroscopy [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 [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 [at 3 months after the initial surgery]

4. Pregnancy rate [at 12-month after the initial surgery]

Secondary Outcome Measures

1. Rate of complications [up to 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FuxingHospital，Captital Medical University	Beijing	Beijing	China	100038

Sponsors and Collaborators

• Fu Xing Hospital, Capital Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yang Xue, principal investigator, Fu Xing Hospital, Capital Medical University
• ClinicalTrials.gov Identifier: NCT05085067
• Other Study ID Numbers: FXHV1.0-2020-11-15
• First Posted: Oct 20, 2021
• Last Update Posted: Apr 8, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yang Xue, principal investigator, Fu Xing Hospital, Capital Medical University: Retained Products of Conception; Hysteroscopy; Intrauterine adhesion; Auto-crossed-linked hyaluronic acid gel
• Additional relevant MeSH terms: Tissue Adhesions; Hyaluronic Acid

Study Results

No Results Posted as of Apr 8, 2022