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OpenTrials
Completed

NCT Number: NCT07169435

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

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.

Completed

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Key information

Conditions

Uterine Caesarean Scar Defect

Age range

18 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, 200030, China

Who can participate

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

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

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

Treatment and study plan

Primary outcomes

  1. the median time to pregnancy following surgery

    Time frame: 2 years

    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

Sponsors and collaborators

Lead sponsor

International Peace Maternity and Child Health Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 11, 2025
Registry last updated
Sep 16, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.