Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF
NCT ID: NCT01798836
Last Updated: 2015-08-06
Study Results
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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TERMINATED
PHASE2/PHASE3
17 participants
INTERVENTIONAL
2013-02-28
2015-02-28
Brief Summary
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Detailed Description
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A major disadvantage of the use of a GnRH antagonist protocol is the limitation for programming cycles, as the drugs administration is started on day 2 of the menstrual cycle and is strictly followed until the hCG criteria are met.
The purpose of the study is to perform oestradiol pre-treatment with the combined ultrashort flare GnRH agonist /GnRH antagonist protocol aiming to
1. better programme an antagonist cycle and
2. improve the IVF outcome parameters, from the production of more follicles / oocytes up to the rise in live birth rates.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oestradiol and ultrashort GnRH agonist/antagonist protocol
Women will begin pretreatment with 4 mg/day of 17 β-estradiol before the combination of GnRH ultashort agonist and antagonist protocol
Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol
GnRH agonist or antagonist protocol.
Women will undergo either a conventional short or long GnRH agonist or an antagonist protocol during COH for IVF
GnRH agonist or antagonist protocol without oestradiol pre-treatment
Interventions
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Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol
GnRH agonist or antagonist protocol without oestradiol pre-treatment
Eligibility Criteria
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Inclusion Criteria
* Patients with AMH \< 1 and/or FSH \>12
* Poor quality of embryos in previous cycles
* Age of patients up to 44 years
Exclusion Criteria
* Patients with sonographically detected hydrosalpinges
* Presence of intramural fibroid distorting the endometrial cavity or submucous myoma or Asherman's syndrome
* Women with thrombofilia disorders
25 Years
44 Years
FEMALE
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Siristatidis Charalampos, MD, PhD
Assistant Professor in Obstetrics and Gynecology/Assisted Reproduction
Principal Investigators
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George Salamalekis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National and Kapodistrian University of Athens
Charalampos Siristatidis, Assistant Professor
Role: PRINCIPAL_INVESTIGATOR
National and Kapodistrian University of Athens
Locations
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Assisted Reproduction Unit, 3rd Department of Obstetrics and Gynecology. Attikon University Hospital
Athens, Attica, Greece
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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030675
Identifier Type: -
Identifier Source: org_study_id
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