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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National and Kapodistrian University of Athens
Sponsor:
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier:
NCT01798836
First received: February 20, 2013
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF

Resource links provided by NLM:


Further study details as provided by National and Kapodistrian University of Athens:

Primary Outcome Measures:
  • Live birth rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Clinical pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of oocytes retrieved [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Top embryo quality at day 2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Biochemical pregnancy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Ectopic pregnancy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Miscarriage rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Positive Pregnancy Test [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   25 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798836

Contacts
Contact: George Salamalekis, MD, PhD 693-664-7099 ext 0030 gsalamalekis2006@gmail.com
Contact: Charalampos Siristatidis, Assistant Professor 693-229-4994 ext 0030 harrysiri@yahoo.gr

Locations
Greece
Assisted Reproduction Unit, 3rd Department of Obstetrics and Gynecology. Attikon University Hospital Recruiting
Athens, Attica, Greece, 12642
Contact: George Salamalekis, MD, PhD    693-664-7099 ext 0030    gsalamalekis2006@gmail.com   
Contact: Charalampos Siristatidis, Assistant Professor    693-229-4994 ext 0030    harrysiri@yahoo.gr   
Sub-Investigator: Maria Kreatsa, MD, PhD         
Sub-Investigator: Charalampos Chrelias, Assistant Prof. Ob/Gyn         
Sub-Investigator: Tereza Vrantza, MSc         
Sub-Investigator: Paraskevi Vogiatzi, MSc         
Sub-Investigator: Eleni Alexiou, Chief midwife         
Sub-Investigator: Dimitrios Kassanos, Prof Ob/Gyn         
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
Principal Investigator: George Salamalekis, MD, PhD National and Kapodistrian University of Athens
Principal Investigator: Charalampos Siristatidis, Assistant Professor National and Kapodistrian University of Athens
  More Information

Publications:
Responsible Party: Siristatidis Charalampos, MD, PhD, Assistant Professor in Obstetrics and Gynecology/Assisted Reproduction, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT01798836     History of Changes
Other Study ID Numbers: 030675
Study First Received: February 20, 2013
Last Updated: November 29, 2013
Health Authority: Ethics Committee: Greece

Keywords provided by National and Kapodistrian University of Athens:
IVF/ICSI cycles, poor responders, ultrashort flare protocol, antagonist protocol

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Triptorelin
Deslorelin
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2014