A Multicenter, Observational Clinical Study of Dydrogesterone

NCT05976529 | Unknown

• 1 other identifier: GuangdongWCH-LiLi02
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Endometriosis Ovary

Keywords

endometriosis; dydrogesterone; therapeutic effect evaluation; safety; dienogest

Outcome Measures

Primary Outcomes (3)

• Visual analogue pain score(VAS)

  The visual analogue scale (VAS) was used to evaluate the pain. It is widely used in clinical practice in China. The basic method is to use a swimming ruler of about 10cm in length, marked with 10 scales on one side, and "0" and "10" points on both ends, with 0 points indicating no pain and 10 points indicating the most severe pain that can be endured.

  before drug treatment and 3 months after drug treatment

• Endometriosis fertility index(EFI)

  EFI score of endometriosis refers to the evaluation of fertility in patients with normal semen in men and good ovarian reserve function in women without adenomyosis. The pregnancy rate was measured by quantifying the patient's age, the duration and type of infertility, and the function of the fallopian tubes, uterus, and ovaries. If the score is higher than 9, the patient can try natural pregnancy. If the score is 5-8 points, the patient can be monitored by fertility guidance, if not naturally pregnant, can be treated by IVF-ET. If the score is lower than 5 points, the patients can be directly treated by IVF-ET.

  before drug treatment and 3 months after drug treatment

• The Cox Menstrual Symptom Scale(CMSS)

  The Cox menstrual symptom scale (CMSS) was used to evaluate the severity of symptoms and the duration of dysmenorrhea. The scale included 2 parts, CMSS-severity (CMSS-S) and CMSS-duration (CMSS-T), with a total of 18 observation indicators. It included 17 symptoms including nausea, vomiting, loss of appetite, headache, vertigo and the duration of dysmenorrhea. All CMSS-S items were scored on a 5-point scale: 0 as no symptoms, 1 as mild, 2 as moderate, 3 as severe, and 4 as extremely severe. CMSS-T is also a 5-point scale: 0 for no symptoms, 1 for persistent \< 3h, 2 for 3\~7h, 3 for 7\~24h, 4 for continuous \> 24 hours.

  before drug treatment and 3 months after drug treatment

Secondary Outcomes (4)

• Serum CA125

  before drug treatment and 3 months after drug treatment

• Anti-mullerian hormone(AMH)

  before drug treatment and 3 months after drug treatment

• Short form 36（SF36）

  before drug treatment and 3 months after drug treatment

• The postoperative pregnancy of the patients.

  3 months after drug treatment

Other Outcomes (2)

• Liver function

  before drug treatment and 3 months after drug treatment

• Kidney function

  before drug treatment and 3 months after drug treatment

Study Arms (2)

study group

From the 5th to 25th day of menstrual cycle, 10 mg dydrogesterone was taken orally twice a day for 3 menstrual cycles.

control group

After postoperative pathological diagnosis, oral dienogest was started, 4 weeks as a course of treatment, and 3 courses of continuous treatment were given.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-45 years after surgery for ovarian endometriosis cyst

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

Study Sites (1)

Guangdong Women and Children Hospital

Guanzhou, Guangdong, 511400, China

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Chen Yuan, Master

  Guangdong Women and Children Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Li, M.D.

CONTACT

+86 13631446859; lili-1406@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Institute of Women's and Children's Health

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: August 4, 2023
• Study Start: January 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

CN (1)