Effect of Shorten Gonadotropin-releasing Hormone Agonist Therapy on the Outcome of in Vitro Fertilization-Embryo Transfer in Patients With Endometriosis

December 29, 2016 updated by: Yingpu Sun, The First Affiliated Hospital of Zhengzhou University
Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which can down-regulate pituitary function causing a temporary low estrogen state. Since endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the growth of endometriosis by inhibiting ovary function.Some scholars have found that, for adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the controls with normal uterus. Thus, the aim of this study is to compare the clinical pregnancy rate in patients treated with GnRH-a for 1, or 2 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • first IVF cycle;
  • with normal ovarian reserve(FSH(10miu/ml； antral follicle count )3)
  • with normal uterine

Exclusion Criteria:

  • Pre-implantation genetic diagnosis cycles;
  • Oocyte donation cycles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Long term GnRH-a for 1 month
patient in this group only receive GnRH-a 3.75 for 1 month
Drug: Long term GnRH-a (3.75mg)
patient in this group only receive GnRH-a 3.75 for pituitary down-regulation
Experimental: patient in this group only receive GnRH-a 3.75 for 2 month
Drug: Long term GnRH-a (3.75mg)
patient in this group only receive GnRH-a 3.75 for pituitary down-regulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical pregnancy rate
Time Frame: 5 weeks after embryo transfer
5 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of oocytes retrieved
Time Frame: 1 day at oocyte retrieved day
1 day at oocyte retrieved day
2 pronucleus(2PN)fertilization rate
Time Frame: 48hours after oocyte retrieved day
Number of 2PN/Matured oocytes
48hours after oocyte retrieved day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Zhengzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimate)

December 30, 2016

Study Record Updates

Last Update Posted (Estimate)

December 30, 2016

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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