Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05206682

Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect

GnRH-a will be used to postpone period after vaginal repair for Cesarean Section Scar Defect(CSD) patients with adenomyosis which will be compared with CSD patients with adenomyosis who receive transvaginal surgery without GnRH-a, whether delayed period improving the CSD prognosis will be assessed.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiaotong University xinhua hospital

Shanghai, Shanghai Municipality, 200092, China

Location status: Recruiting

Location contact

Xipeng Wang

CONTACT

13817806602

About this study

Women with CSD complicated with adenomyosis will be enrolled in this study. They all will receive vaginal excision and suture of CSD and will be required to undergo examinations at 6-months after surgery.

Interventioned group will be subcutaneous injected of Leuprorelin to postpone period after vaginal repair. It is be assumed that temporary menopause could improve inner conditions of uterus, there would be less local inflammation reaction which would be beneficial to the scar healed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clearly diagnosed with CSD complicated with adenomyosis
  • Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 10 days).
  • The thickness of the remaining muscular layer of CSD was less than 3 mm.
  • Normal range of blood sugar and insulin
  • No serious medical problems (important viscera function in the normal range).
  • uterine fibroids no more than 5cm
  • Sign the informed consent.

Exclusion criteria

  • Indefinite diagnosis.
  • Malignant tumors.
  • With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
  • Pregnant.
  • Mental diseases.
  • Allergy to the any ingredients of Leuprorelin
  • Unwilling to comply with the research plan.

Treatment and study plan

leuprorelin

Drug

Leuprorelin will be used to postpone period after vaginal repair.

Primary outcomes

  1. thickness of the remaining muscular layer (TRM) (mm)

    Time frame: 12 weeks after vaginal repair of CSD

    The thickness of the remaining muscular layer is measured by magnetic resonance imaging (MRI)

  2. Duration of menstruation (day)

    Time frame: 12 weeks after vaginal repair of CSD

    Duration of menstruation (day)

Study contacts

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

Wang Xipeng

CONTACT

[email protected]

+862125078999 ext. 6143

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 25, 2022
Registry last updated
Apr 24, 2026

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.

Published trials that share one or more normalized conditions with this study.