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

Peking University

Status: Unknown

Conditions: Infertility Associated With Endometriosis

Treatments: Drug: Goserelin Acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT02779387

PKU01001

Details and patient eligibility

About

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.

Enrollment: 1,184 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,184 participants in 2 patient groups

GnRH-a

Experimental group

Description:

patients treated with GnRH-a after surgery and Outpatient guidance .

Treatment:

Drug: Goserelin Acetate

non GnRH-a

No Intervention group

Description:

patients treated with outpatient guidance only.