Reproductive Outcome of EM Treated by GnRH-a Associated W... | NCT02779387

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

NCT02779387

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

May 20, 2016Estimated

Enrollment

1,184Estimated

Phase

Not Applicable

Conditions

Infertility Associated With Endometriosis

Interventions

Goserelin Acetate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

May 2020Estimated

Completion Date

May 2021Estimated

First Submitted Date

May 18, 2016

First Submission Date that Met QC Criteria

May 19, 2016

First Posted Date

May 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2016

Last Update Posted Date

May 20, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yu xiaoming, Clinician from Department of reproductive medicine.Secretary general of Fallopian tube group,Society for reproductive surgery, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,184Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GnRH-a	Experimental	patients treated with GnRH-a after surgery and Outpatient guidance .	Drug: Goserelin Acetate
non GnRH-a	No Intervention	patients treated with outpatient guidance only.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Goserelin Acetate	Drug		GnRH-a

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative pregnancy rate	Cumulative pregnancy rate of 18 month after surgery	18 month after surgery
Time interval between surgery and natural pregnancy	Time interval between surgery and natural pregnancy	18 month after surgery
miscarriage rate	miscarriage rate of patients who get natural pregnancy	18 month after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Willing to share IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017273	Goserelin

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided