Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF
|ClinicalTrials.gov Identifier: NCT01798836|
Recruitment Status : Terminated (Obtained results were not good. Protocol was proved ineffective.)
First Posted : February 26, 2013
Last Update Posted : August 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Procedure: Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol Procedure: GnRH agonist or antagonist protocol without oestradiol pre-treatment||Phase 2 Phase 3|
The combined ultrashort flare GnRH agonist /GnRH antagonist protocol during COH cycle resulted in a significantly higher clinical pregnancy rate in patients with poor embryo quality, with repeated IVF failures and in poor responders. This is a protocol combining the effect of the microdose flare on endogenous FSH release with the benefit of an immediate LH suppression of the GnRH antagonist.
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
- better programme an antagonist cycle and
- improve the IVF outcome parameters, from the production of more follicles / oocytes up to the rise in live birth rates.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||February 2015|
Experimental: 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
Procedure: Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol
Active Comparator: GnRH agonist or antagonist protocol.
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
- Live birth rate [ Time Frame: 2 years ]
- Clinical pregnancy rate [ Time Frame: 2 years ]
- Number of oocytes retrieved [ Time Frame: 2 years ]
- Top embryo quality at day 2 [ Time Frame: 2 years ]
- Biochemical pregnancy [ Time Frame: 2 years ]
- Ectopic pregnancy [ Time Frame: 2 years ]
- Miscarriage rate [ Time Frame: 2 years ]
- Positive Pregnancy Test [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798836
|Assisted Reproduction Unit, 3rd Department of Obstetrics and Gynecology. Attikon University Hospital|
|Athens, Attica, Greece, 12642|
|Principal Investigator:||George Salamalekis, MD, PhD||National and Kapodistrian University of Athens|
|Principal Investigator:||Charalampos Siristatidis, Assistant Professor||National and Kapodistrian University of Athens|