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

NCT02779387 | Unknown

• 1 other identifier: PKU01001
• Study Type: interventional
• Target: 1,184
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility Associated With Endometriosis

Keywords

GnRH-a; endometriosis; efficiency

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Goserelin Acetate DRUG

GnRH-a

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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）

You may not qualify if:

• Male factor causes infertility
• hydrosalpinx or salpingemphraxis
• Uterine malformation
• Uterine cavity lesion
• Contra-indications for GnRH-a
• not willing to participate

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Endometriosis

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician from Department of reproductive medicine.Secretary general of Fallopian tube group,Society for reproductive surgery

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 20, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2021
• Last Updated: May 20, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share