Clinical trial NCT01798836: Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF
Official title: Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Infertility
Keywords: IVF/ICSI cycles, poor responders, ultrashort flare protocol, antagonist protocol
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 17
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Live birth rate
timeFrame: 2 years
measure: Clinical pregnancy rate
timeFrame: 2 years
Secondary outcomes:
measure: Number of oocytes retrieved
timeFrame: 2 years
measure: Top embryo quality at day 2
timeFrame: 2 years
measure: Biochemical pregnancy
timeFrame: 2 years
measure: Ectopic pregnancy
timeFrame: 2 years
measure: Miscarriage rate
timeFrame: 2 years
Other outcomes:
measure: Positive Pregnancy Test
timeFrame: 2 years
Locations:
city: Athens
country: Greece
facility: Assisted Reproduction Unit, 3rd Department of Obstetrics and Gynecology. Attikon University Hospital
state: Attica
Study officials:
affiliation: National and Kapodistrian University of Athens
name: George Salamalekis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National and Kapodistrian University of Athens
name: Charalampos Siristatidis, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.