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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

Primary Purpose

Clinical Pregnancy Rate

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Long term GnRH-a (3.75mg)

About this trial

This is an interventional treatment trial for Clinical Pregnancy Rate focused on measuring endometriosis, long term GnRH-a

Eligibility Criteria

22 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Long term GnRH-a for 1 month

patient in this group only receive GnRH-a 3.75 for 2 month

Arm Description

patient in this group only receive GnRH-a 3.75 for 1 month

patient in this group only receive GnRH-a 3.75 for 2 month

Outcomes

Primary Outcome Measures

clinical pregnancy rate

Secondary Outcome Measures

Number of oocytes retrieved

2 pronucleus(2PN)fertilization rate

Number of 2PN/Matured oocytes

Full Information

NCT ID

NCT03006406

First Posted

December 28, 2016

Last Updated

December 29, 2016

Sponsor

The First Affiliated Hospital of Zhengzhou University

1. Study Identification

Unique Protocol Identification Number

NCT03006406

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital of Zhengzhou University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clinical Pregnancy Rate

Keywords

endometriosis, long term GnRH-a

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Long term GnRH-a for 1 month

Arm Type

Active Comparator

Arm Description

patient in this group only receive GnRH-a 3.75 for 1 month

Arm Title

patient in this group only receive GnRH-a 3.75 for 2 month

Arm Type

Experimental

Arm Description

patient in this group only receive GnRH-a 3.75 for 2 month

Intervention Type

Drug

Intervention Name(s)

Long term GnRH-a (3.75mg)

Intervention Description

patient in this group only receive GnRH-a 3.75 for pituitary down-regulation

Primary Outcome Measure Information:

Title

clinical pregnancy rate

Time Frame

5 weeks after embryo transfer

Secondary Outcome Measure Information:

Title

Number of oocytes retrieved

Time Frame

1 day at oocyte retrieved day

Title

2 pronucleus(2PN)fertilization rate

Description

Number of 2PN/Matured oocytes

Time Frame

48hours after oocyte retrieved day

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huijuan Kong, M.D.

Phone

86-371-67966161

luckyjuanjuan819@126.com

Facility Information:

Facility Name

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yingpu Ms Sun, M.D,PhD

Phone

86-13803841888

syp2008@vip.sina.com

First Name & Middle Initial & Last Name & Degree

Zhiqin Mr Bu, MD

Phone

86-15981978863

rmczzu@126.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

24262434

Citation

van der Houwen LE, Mijatovic V, Leemhuis E, Schats R, Heymans MW, Lambalk CB, Hompes PG. Efficacy and safety of IVF/ICSI in patients with severe endometriosis after long-term pituitary down-regulation. Reprod Biomed Online. 2014 Jan;28(1):39-46. doi: 10.1016/j.rbmo.2013.09.027. Epub 2013 Oct 9.

Results Reference

background

PubMed Identifier

20409633

Citation

Mijatovic V, Florijn E, Halim N, Schats R, Hompes P. Adenomyosis has no adverse effects on IVF/ICSI outcomes in women with endometriosis treated with long-term pituitary down-regulation before IVF/ICSI. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):62-5. doi: 10.1016/j.ejogrb.2010.02.047. Epub 2010 Apr 21.

Results Reference

background

PubMed Identifier

30572916

Citation

Kong H, Hu L, Nie L, Yu X, Dai W, Li J, Chen C, Bu Z, Shi H, Wu Q, Guan Y, Sun Y. A multi-center, randomized controlled clinical trial of the application of a shortened protocol of long-acting Triptorelin down-regulated prior to IVF/ICSI among patients with endometriosis: A protocol. Reprod Health. 2018 Dec 20;15(1):213. doi: 10.1186/s12978-018-0639-8.

Results Reference

derived

Learn more about this trial

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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