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

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ClinicalTrials.gov Identifier: NCT03006406
Recruitment Status : Unknown
Verified December 2016 by Yingpu Sun, The First Affiliated Hospital of Zhengzhou University.
Recruitment status was:  Recruiting
First Posted : December 30, 2016
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
Yingpu Sun, The First Affiliated Hospital of Zhengzhou University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Clinical Pregnancy Rate Drug: Long term GnRH-a (3.75mg) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 5 weeks after embryo transfer ]

Secondary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: 1 day at oocyte retrieved day ]
  2. 2 pronucleus(2PN)fertilization rate [ Time Frame: 48hours after oocyte retrieved day ]
    Number of 2PN/Matured oocytes


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006406


Contacts
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Contact: Huijuan Kong, M.D. 86-371-67966161 luckyjuanjuan819@126.com

Locations
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China, Henan
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Yingpu Ms Sun, M.D,PhD    86-13803841888    syp2008@vip.sina.com   
Contact: Zhiqin Mr Bu, MD    86-15981978863    rmczzu@126.com   
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yingpu Sun, Director of Reproductive Medical Center,1st Affilated Hospital, Zhengzhou University, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT03006406    
Other Study ID Numbers: ENDO-1
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yingpu Sun, The First Affiliated Hospital of Zhengzhou University:
endometriosis
long term GnRH-a
Additional relevant MeSH terms:
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Endometriosis