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Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation

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ClinicalTrials.gov Identifier: NCT01319708
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens

Study Description
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Brief Summary:
The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF.

Condition or disease Intervention/treatment Phase
Infertility Procedure: mild ovarian stimulation Procedure: conventional ovarian stimulation Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation
Study Start Date : March 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: mild ovarian stimulation
100 mg CC by day 2 till 6, plus antagonist plus gonadotrophin 150-200IO until HCG triggering
 Procedure: mild ovarian stimulation
100-150 mg of clomiphene citrate from day 2 till day 6 of the cycle and 150 mg of gonadotrophins as soon as 1 follicle is more than 14mm together with 1 fixed dose of GnRH antagonist until egg recovery
Active Comparator: conventional ovarian stimulation
300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses using a GnRH agonist long protocol
 Procedure: conventional ovarian stimulation
300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses with GnRH agonist long protocol


Outcome Measures
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Primary Outcome Measures :
  1. number of oocytes (COCs) [ Time Frame: at oocyte recovery ]

Secondary Outcome Measures :
  1. Number/rate of participants whom the IVF cycle was cancelled [ Time Frame: After the 1st week of ovarian stimulation, no oocytes at OR ]
  2. clinical pregnancy rate [ Time Frame: 6 weeks ]
    Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention

  3. live birth [ Time Frame: more than 20 weeks ]
  4. miscarriage [ Time Frame: pregnancy loss before 20 weeks of gestation, after a positive pregnancy test ]
  5. stimulation characteristics [ Time Frame: from start of stimulation until embryo transfer ]
    total dose of gonadotropins administered,

  6. cancellation rate [ Time Frame: from start of stimulation until ET ]
    when premature ovulation was evident by the loss of follicle(s) prior to oocyte recovery, and in cases where there were no oocytes retrieved or no embryos produced for transfer and in failed fertilization


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • poor responders (age>40, previous POR, abnormal OR test)
  • indication for IVF
  • regular cycling patients
  • BMI 19-35

Exclusion Criteria:

  • contraindication for clomiphene citrate use or to GnRH agonists antagonists
  • BMI > 35
Contacts and Locations
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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): NCT01319708


Locations
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Greece
3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit
Athens, Chaidari, Greece, 12462
Sponsors and Collaborators
National and Kapodistrian University of Athens
More Information
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Responsible Party: Siristatidis Charalampos, MD, PhD, Assistant Professor, Director of the ARU, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT01319708    
Other Study ID Numbers: 1234561
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015
Keywords provided by Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens:
ovarian stimulation
climiphene citrate
Gonadotropin-Releasing Hormone agonists/antagonists
Follicle Stimulating Hormone
Additional relevant MeSH terms:
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Infertility