Reproductive Outcome of EM Treated by GnRH-a Associated With Laparoscopy

Infertility Associated With Endometriosis Clinical Trial

Official title:

Efficacy of Laparoscopic Surgery Combined With GnRH-a in the Treatment of Endometriosis Associated Infertility: A Multicenter, Prospective, Randomized-control-trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02779387
• Other study ID #: PKU01001
• Status: Not yet recruiting
• Phase: N/A
• First received: May 18, 2016
• Last updated: May 19, 2016
• Start date: May 2016
• Est. completion date: May 2021

Study information

• Verified date: May 2016
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

This study is a multicenter, randomized-control-trial. This study select 1184 Infertile patients associated with endometriosis diagnosed by laparoscopy surgery. Patients are going to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a. Cumulative pregnancy rate, end of treatment to natural pregnancy time, accept the assisted reproductive treatment rate, miscarriage rate, live birth rate will be recorded.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1184
• Est. completion date: May 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Infertile patients

• Endometriosis I-II phase:according to Revised American Society for Reproductive Medicine classification of endometriosis: 1996

• BMI:19-28 kg/?

• Ovarian reserve function is normal(M2-5:bilateral antral follicles=6 FSH:5-12U/ml)

Exclusion Criteria:

• Male factor causes infertility

• hydrosalpinx or salpingemphraxis

• Uterine malformation

• Uterine cavity lesion

• Contra-indications for GnRH-a

• not willing to participate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Infertility
• Infertility Associated With Endometriosis

Intervention

Drug:
• Goserelin Acetate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative pregnancy rate	Cumulative pregnancy rate of 18 month after surgery	18 month after surgery	No
Primary	Time interval between surgery and natural pregnancy	Time interval between surgery and natural pregnancy	18 month after surgery	No
Primary	miscarriage rate	miscarriage rate of patients who get natural pregnancy	18 month after surgery	No