Status:

UNKNOWN

A Multicenter, Observational Clinical Study of Dydrogesterone

Lead Sponsor:

Guangdong Women and Children Hospital

Conditions:

Endometriosis

Endometriosis Ovary

Eligibility:

FEMALE

18-45 years

Brief Summary

The objective of this study was to investigate the efficacy and safety of dydrogesterone in the long-term management of ovarian endometriosis cyst after surgery.

Detailed Description

Endometriosis refers to the appearance, growth and infiltration of endometrial tissue (glands and stroma) in the lining of the uterine cavity and other parts of the uterus, and repeated bleeding, whic...

Eligibility Criteria

Inclusion

  • Patients who had undergone laparoscopic ovarian cyst excision and were confirmed by pathological diagnosis as ovarian endometriosis cyst (pathology was completed in each central hospital).
  • Ovarian cyst \>4cm.
  • Concomitant infertility.
  • Patients who fail to respond to medication.
  • American Society of Reproductive Medicine(ASRM) stages were II-IV.
  • No relevant therapeutic drugs, such as dydrogesterone, dienogest, GnRHa, etc., were used 3 months before treatment.
  • No combined endocrine diseases.

Exclusion

  • Ovulation disorders, immune defects and genital development abnormalities caused by infertility.
  • Patients who are allergic to the drugs used in this study.
  • Patients with severe hepatorenal insufficiency or malignant tumor.
  • Those who took hormone medication within 3 months before the study date.

Key Trial Info

Start Date :

January 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT05976529

Start Date

January 1 2023

End Date

December 31 2025

Last Update

October 23 2023

Active Locations (1)

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Guangdong Women and Children Hospital

Guanzhou, Guangdong, China, 511400

A Multicenter, Observational Clinical Study of Dydrogesterone | DecenTrialz