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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

NCT ID: NCT03006406

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Clinical Pregnancy Rate

Keywords

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endometriosis long term GnRH-a

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Long term GnRH-a for 1 month

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

Group Type ACTIVE_COMPARATOR

Long term GnRH-a (3.75mg)

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Long term GnRH-a (3.75mg)

Intervention Type DRUG

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

Interventions

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Long term GnRH-a (3.75mg)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Yingpu Sun

Director of Reproductive Medical Center,1st Affilated Hospital, Zhengzhou University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huijuan Kong, M.D.

Role: CONTACT

Phone: 86-371-67966161

Email: [email protected]

Facility Contacts

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Yingpu Ms Sun, M.D,PhD

Role: primary

Zhiqin Mr Bu, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 24262434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20409633 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30572916 (View on PubMed)

Other Identifiers

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ENDO-1

Identifier Type: -

Identifier Source: org_study_id