NCT01798836

Brief Summary

To evaluate the effect of oestradiol pre-treatment in a combined ultrashort flare GnRH agonist /GnRH antagonist protocol

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

1.9 years

First QC Date

February 20, 2013

Last Update Submit

August 4, 2015

Conditions

Infertility

Keywords

IVF/ICSI cycles, poor responders, ultrashort flare protocol, antagonist protocol

Outcome Measures

Primary Outcomes (2)

  • Live birth rate

    2 years

  • Clinical pregnancy rate

    2 years

Secondary Outcomes (5)

  • Number of oocytes retrieved

    2 years

  • Top embryo quality at day 2

    2 years

  • Biochemical pregnancy

    2 years

  • Ectopic pregnancy

    2 years

  • Miscarriage rate

    2 years

Other Outcomes (1)

  • Positive Pregnancy Test

    2 years

Study Arms (2)

Oestradiol and ultrashort GnRH agonist/antagonist protocol

EXPERIMENTAL

Women will begin pretreatment with 4 mg/day of 17 β-estradiol before the combination of GnRH ultashort agonist and antagonist protocol

Procedure: Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol

GnRH agonist or antagonist protocol.

ACTIVE COMPARATOR

Women will undergo either a conventional short or long GnRH agonist or an antagonist protocol during COH for IVF

Procedure: GnRH agonist or antagonist protocol without oestradiol pre-treatment

Interventions

Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocolPROCEDURE
Oestradiol and ultrashort GnRH agonist/antagonist protocol
GnRH agonist or antagonist protocol without oestradiol pre-treatmentPROCEDURE
GnRH agonist or antagonist protocol.

Eligibility Criteria

Age25 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with poor or no response in previous COH for IVF cycles
  • Patients with AMH \< 1 and/or FSH \>12
  • Poor quality of embryos in previous cycles
  • Age of patients up to 44 years

You may not qualify if:

  • Patients with normal ovarian reserve
  • Patients with sonographically detected hydrosalpinges
  • Presence of intramural fibroid distorting the endometrial cavity or submucous myoma or Asherman's syndrome
  • Women with thrombofilia disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assisted Reproduction Unit, 3rd Department of Obstetrics and Gynecology. Attikon University Hospital

Athens, Attica, 12642, Greece

Location

Related Publications (4)

  • Griesinger G, Kolibianakis EM, Venetis C, Diedrich K, Tarlatzis B. Oral contraceptive pretreatment significantly reduces ongoing pregnancy likelihood in gonadotropin-releasing hormone antagonist cycles: an updated meta-analysis. Fertil Steril. 2010 Nov;94(6):2382-4. doi: 10.1016/j.fertnstert.2010.04.025. Epub 2010 May 26.

    PMID: 20537631BACKGROUND

  • Bosch E. Can we skip weekends in GnRH antagonist cycles without compromising the final outcome? Fertil Steril. 2012 Jun;97(6):1299-300. doi: 10.1016/j.fertnstert.2012.04.024. No abstract available.

    PMID: 22656307BACKGROUND

  • Orvieto R, Nahum R, Rabinson J, Gemer O, Anteby EY, Meltcer S. Ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist for patients with repeated IVF failures and poor embryo quality. Fertil Steril. 2009 Apr;91(4 Suppl):1398-400. doi: 10.1016/j.fertnstert.2008.04.064. Epub 2008 Aug 3.

    PMID: 18675974RESULT

  • Cedrin-Durnerin I, Guivarc'h-Leveque A, Hugues JN; Groupe d'Etude en Medecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.

    PMID: 22464760RESULT

MeSH Terms

Conditions

Infertility

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • George Salamalekis, MD, PhD

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

  • Charalampos Siristatidis, Assistant Professor

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Obstetrics and Gynecology/Assisted Reproduction

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 26, 2013

Study Start

February 1, 2013

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

GR(1)