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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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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
Sponsor:
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens

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

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Live birth rate [ Time Frame: 2 years ]
  2. Clinical pregnancy rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: 2 years ]
  2. Top embryo quality at day 2 [ Time Frame: 2 years ]
  3. Biochemical pregnancy [ Time Frame: 2 years ]
  4. Ectopic pregnancy [ Time Frame: 2 years ]
  5. Miscarriage rate [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Positive Pregnancy Test [ Time Frame: 2 years ]


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Ages Eligible for Study:   25 Years to 44 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

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


Locations
Greece
Assisted Reproduction Unit, 3rd Department of Obstetrics and Gynecology. Attikon University Hospital
Athens, Attica, Greece, 12642
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

Publications of Results:
Other 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
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015

Keywords provided by Siristatidis Charalampos, MD, PhD, 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
Prolactin Release-Inhibiting Factors
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Triptorelin Pamoate
Deslorelin
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents