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.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section; Dehiscence
• Intervention / Treatment: Drug: Leuprorelin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang Xipeng; Phone Number: 6143 +862125078999; Email: steveoizzie@icloud.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200092
      • Recruiting
      • Shanghai Jiaotong University xinhua hospital
      • Contact: Xipeng Wang; Phone Number: 13817806602

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginal Repair with Leuprorelin; CSD patients were treated with vaginal repair of CSD in combination with Leuprorelin . In the group of Vaginal Repair With Leuprorelin, the patients will get 3 times of Leuprorelin per 4 weeks perioperation. The detailed procedure of Vaginal Repair has been described in our previous study.	Drug: Leuprorelin; Leuprorelin will be used to postpone period after vaginal repair.
No Intervention: Vaginal Repair without Leuprorelin; The detailed procedure of Vaginal Repair has been described in our previous study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thickness of the remaining muscular layer (TRM) (mm)	The thickness of the remaining muscular layer is measured by magnetic resonance imaging (MRI)	12 weeks after vaginal repair of CSD
Duration of menstruation (day)	Duration of menstruation (day)	12 weeks after vaginal repair of CSD

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Zoladex; vaginal repair; Cesarean Section Scar Defect
• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropin-Releasing Hormone; Leuprolide
• Other Study ID Numbers: XH-21-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No