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Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF

Primary Purpose

Infertility

Status
Terminated
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol
GnRH agonist or antagonist protocol without oestradiol pre-treatment
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF/ICSI cycles, poor responders, ultrashort flare protocol, antagonist protocol

Eligibility Criteria

25 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oestradiol and ultrashort GnRH agonist/antagonist protocol

GnRH agonist or antagonist protocol.

Arm Description

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

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

Outcomes

Primary Outcome Measures

Live birth rate
Clinical pregnancy rate

Secondary Outcome Measures

Number of oocytes retrieved
Top embryo quality at day 2
Biochemical pregnancy
Ectopic pregnancy
Miscarriage rate

Full Information

First Posted
February 20, 2013
Last Updated
August 4, 2015
Sponsor
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT01798836
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Obtained results were not good. Protocol was proved ineffective.
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF/ICSI cycles, poor responders, ultrashort flare protocol, antagonist protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oestradiol and ultrashort GnRH agonist/antagonist protocol
Arm Type
Experimental
Arm Description
Women will begin pretreatment with 4 mg/day of 17 β-estradiol before the combination of GnRH ultashort agonist and antagonist protocol
Arm Title
GnRH agonist or antagonist protocol.
Arm Type
Active Comparator
Arm Description
Women will undergo either a conventional short or long GnRH agonist or an antagonist protocol during COH for IVF
Intervention Type
Procedure
Intervention Name(s)
Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol
Intervention Type
Procedure
Intervention Name(s)
GnRH agonist or antagonist protocol without oestradiol pre-treatment
Primary Outcome Measure Information:
Title
Live birth rate
Time Frame
2 years
Title
Clinical pregnancy rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of oocytes retrieved
Time Frame
2 years
Title
Top embryo quality at day 2
Time Frame
2 years
Title
Biochemical pregnancy
Time Frame
2 years
Title
Ectopic pregnancy
Time Frame
2 years
Title
Miscarriage rate
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Positive Pregnancy Test
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Salamalekis, MD, PhD
Organizational Affiliation
National and Kapodistrian University of Athens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charalampos Siristatidis, Assistant Professor
Organizational Affiliation
National and Kapodistrian University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assisted Reproduction Unit, 3rd Department of Obstetrics and Gynecology. Attikon University Hospital
City
Athens
State/Province
Attica
ZIP/Postal Code
12642
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
20537631
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.
Results Reference
background
PubMed Identifier
22656307
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.
Results Reference
background
PubMed Identifier
18675974
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.
Results Reference
result
PubMed Identifier
22464760
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.
Results Reference
result

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Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF

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