Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF
NCT ID: NCT02173977
Last Updated: 2014-06-25
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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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2014-06-30
2017-05-31
Brief Summary
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The investigators hypothesized that combining the stimulatory effect of GnRH agonists and immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH strategy for IVF patients, resulting in improved ART outcome.
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Detailed Description
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The basic hypothesis of this approach can also benefit IVF patients with good prognosis without compromising the ability to use gonadotrophin-releasing hormone (GnRH) agonist to effectively trigger ovulation, while completely eliminating any threat of clinically significant ovarian hyperstimulation syndrome (OHSS).
The purpose of the study is to compare cycles consisting of ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist with those using the flexible multidose GnRH antagonist protocol
1\. To compare the IVF outcome variables and ongoing pregnancy rates.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARM A- Agonist/Antagonist protocol
The Ultrashort GnRH Agonist/antagonist method entails pre-treatment with oral contraceptive pills before the combination of GnRH ultrashort agonist and antagonist protocol
ARM A- Agonist/Antagonist protocol
In vitro fertilization (IVF/ICSI)
ARM B- Antagonist protocol
In vitro fertilization (IVF/ICSI)
ARM B- Antagonist protocol
The standard IVF method entails Flexible Multidose GnRH Antagonist protocol during COH
ARM A- Agonist/Antagonist protocol
In vitro fertilization (IVF/ICSI)
ARM B- Antagonist protocol
In vitro fertilization (IVF/ICSI)
Interventions
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ARM A- Agonist/Antagonist protocol
In vitro fertilization (IVF/ICSI)
ARM B- Antagonist protocol
In vitro fertilization (IVF/ICSI)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Abnormal ovarian reserve test i.e. anti-mullerian hormone (AMH), Antral follicle test
* Risk factor for Diminished Ovarian Reserve
20 Years
35 Years
FEMALE
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Raoul Orvieto, MD
Role: PRINCIPAL_INVESTIGATOR
Infertility & IVF Unit, Dept. Obstetrics & Gynecology - Director
Locations
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Sheba Medical Center- IVF unit
Ramat Gan, Israel, Israel
Countries
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References
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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.
Orvieto R. The ultrashort flare GnRH-agonist/GnRH-antagonist protocol enables cycle programming and may overcome the "detrimental effect" of the oral contraceptive. Fertil Steril. 2012 Sep;98(3):e17-8; author reply e19. doi: 10.1016/j.fertnstert.2012.06.053. Epub 2012 Jul 26. No abstract available.
Orvieto R, Nahum R, Zohav E, Liberty G, Anteby EY, Meltcer S. GnRH-agonist ovulation trigger in patients undergoing controlled ovarian hyperstimulation for IVF with ultrashort flare GnRH-agonist combined with multidose GnRH-antagonist protocol. Gynecol Endocrinol. 2013 Jan;29(1):51-3. doi: 10.3109/09513590.2012.705376. Epub 2012 Aug 3.
Orvieto R, Meltcer S, Liberty G, Rabinson J, Anteby EY, Nahum R. A combined approach to patients with repeated IVF failures. Fertil Steril. 2010 Nov;94(6):2462-4. doi: 10.1016/j.fertnstert.2010.03.057. Epub 2010 May 7.
Orvieto R, Kruchkovich J, Rabinson J, Zohav E, Anteby EY, Meltcer S. Ultrashort gonadotropin-releasing hormone agonist combined with flexible multidose gonadotropin-releasing hormone antagonist for poor responders in in vitro fertilization/embryo transfer programs. Fertil Steril. 2008 Jul;90(1):228-30. doi: 10.1016/j.fertnstert.2007.06.022. Epub 2007 Aug 6.
Other Identifiers
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SHEBA-14-1078-RO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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