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

NCT ID: NCT02779387

Last Updated: 2016-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility Associated With Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GnRH-a

patients treated with GnRH-a after surgery and Outpatient guidance

.

Group Type EXPERIMENTAL

Goserelin Acetate

Intervention Type DRUG

non GnRH-a

patients treated with outpatient guidance only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Goserelin Acetate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu xiaoming

Clinician from Department of reproductive medicine.Secretary general of Fallopian tube group,Society for reproductive surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PKU01001

Identifier Type: -

Identifier Source: org_study_id

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