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

NCT02779387 — Not applicable, Unknown, 1184 participants, Peking University People's Hospital

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

Registry	NCT02779387
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	1184 (Estimated)
Sponsor	Peking University People's Hospital (Other)
Conditions	Infertility Associated With Endometriosis
Interventions	Goserelin Acetate (Drug)
Dates	start 2016-05-01, primary completion 2020-05-01 (estimated), completion 2021-05-01 (estimated), first posted 2016-05-20, last updated 2016-05-20

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
GnRH-a	Experimental	Drug: Goserelin Acetate	patients treated with GnRH-a after surgery and Outpatient guidance .
non GnRH-a	No intervention		patients treated with outpatient guidance only.

Goserelin Acetate (Drug)

+Outcome measures

Primary outcomes

Cumulative pregnancy rate [18 month after surgery]: Cumulative pregnancy rate of 18 month after surgery
Time interval between surgery and natural pregnancy [18 month after surgery]: Time interval between surgery and natural pregnancy
miscarriage rate [18 month after surgery]: miscarriage rate of patients who get natural pregnancy

+Eligibility

Sex: Female, ages: 20 Years to 35 Years

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