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CompletedNCT07169435Updated Sep 16, 2025

Enhanced Reproductive Efficiency: Shorter Time to Pregnancy After Hysteroscopic-Assisted Novel Transvaginal Repair

An observational study in Uterine Caesarean Scar Defect, sponsored by International Peace Maternity and Child Health Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 48 Years. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by International Peace Maternity and Child Health Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 48 Years
Sex
Female
01

Study summary

To investigate whether a novel hysteroscopic-assisted transvaginal repair technique results in a shorter time to pregnancy and superior fertility outcomes compared to traditional transvaginal repair.

02

Conditions studied

  • Uterine Caesarean Scar Defect
03

In context

Lead sponsor

International Peace Maternity and Child Health Hospital is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 48 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

This prospective cohort study was conducted between May 2019 and May 2023 at Department of Gynecology and Obstetrics, International Peace Maternity and Child Health Hospital (IPMCH), Jiao Tong University School of Medicine, Shanghai, China.

Inclusion criteria

Patients with a large niche (defined as niche with a depth of >50% of the myometrial thickness and a residual myometrial thickness (RMT) ≤3mm) Patients have fertility requirements Patients were aged between 18 and 48 years Patients who requested transvaginal surgery (the final decision about operation method was made by the patient (shared decision making))

Exclusion criteria

Exclusion Criteria:

Patients with a narrow vaginal canal or any evidence of severe pelvic adhesion around the uterus Patients with post-operative biopsy-proven atypical endometrial hyperplasia and endometrial cancer

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Hysteroscopic-assisted novel transvaginal repair

    Traditional transvaginal repair (TTR) procedure mainly involves two steps: the obvious scar-like defect excision and the full-thickness myometrial closure, which maybe form a new scar defect due to the uncertain scar healing process.

  • Traditional transvaginal repair

    Hysteroscopic-assisted novel transvaginal repair (NTR) surgery does not need to remove the original scar defect. Instead, suture was used to interruptedly suture the myometrium at the upper and lower margins of the scar to close the niche or reduce its size, which retains the integrity of the myometrium.

06

What researchers measure

Primary outcomes

  1. the median time to pregnancy following surgery

    It is the time point at which half of the patients in the study who attempted to conceive after surgery had successfully become pregnant, and the other half had not

    Time frame: 2 years

07

Study locations

1 site
  • International Peace Maternity and Child Health Hospital
    Shanghai, Shanghai Municipality 200030, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07169435
Lead sponsor
International Peace Maternity and Child Health Hospital
Responsible party
Sponsor
First posted
Sep 11, 2025
Start date
May 1, 2019
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023
Last update
Sep 16, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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