NCT03006406

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

December 28, 2016

Last Update Submit

December 29, 2016

Conditions

Clinical Pregnancy Rate

Keywords

endometriosislong term GnRH-a

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    5 weeks after embryo transfer

Secondary Outcomes (2)

  • Number of oocytes retrieved

    1 day at oocyte retrieved day

  • 2 pronucleus(2PN)fertilization rate

    48hours after oocyte retrieved day

Study Arms (2)

Long term GnRH-a for 1 month

ACTIVE COMPARATOR

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 2 month

EXPERIMENTAL

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

Drug: Long term GnRH-a (3.75mg)

Interventions

Long term GnRH-a (3.75mg)DRUG

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

Long term GnRH-a for 1 monthpatient in this group only receive GnRH-a 3.75 for 2 month

Eligibility Criteria

Age22 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 24262434BACKGROUND

  • 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.

    PMID: 20409633BACKGROUND

  • 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.

    PMID: 30572916DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Huijuan Kong, M.D.

CONTACT

86-371-67966161luckyjuanjuan819@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Reproductive Medical Center,1st Affilated Hospital, Zhengzhou University

Study Record Dates

First Submitted

December 28, 2016

First Posted

December 30, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2018

Last Updated

December 30, 2016

Record last verified: 2016-12

Locations

CN(1)