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

NCT07169435 | Completed DMC

• 1 other identifier: (GKLW)2018-23
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Caesarean Scar Defect

Outcome Measures

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

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• International Peace Maternity and Child Health Hospital: lead

Study Sites (1)

International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: May 1, 2019
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)