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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier:
NCT01319708
First received: March 8, 2011
Last updated: November 7, 2015
Last verified: November 2015
  Purpose
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 Intervention Phase
Infertility
Procedure: mild ovarian stimulation
Procedure: conventional ovarian stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation

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

Primary Outcome Measures:
  • number of oocytes (COCs) [ Time Frame: at oocyte recovery ] [ Designated as safety issue: No ]

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

  • live birth [ Time Frame: more than 20 weeks ] [ Designated as safety issue: No ]
  • miscarriage [ Time Frame: pregnancy loss before 20 weeks of gestation, after a positive pregnancy test ] [ Designated as safety issue: No ]
  • stimulation characteristics [ Time Frame: from start of stimulation until embryo transfer ] [ Designated as safety issue: No ]
    total dose of gonadotropins administered,

  • cancellation rate [ Time Frame: from start of stimulation until ET ] [ Designated as safety issue: No ]
    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


Enrollment: 50
Study Start Date: March 2011
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Genders 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01319708

Locations
Greece
3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit
Athens, Chaidari, Greece, 12462
Sponsors and Collaborators
National and Kapodistrian University of Athens
  More Information

Responsible Party: Siristatidis Charalampos, MD, PhD, Assistant Professor, Director of the ARU, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT01319708     History of Changes
Other Study ID Numbers: 1234561 
Study First Received: March 8, 2011
Last Updated: November 7, 2015
Health Authority: United States: Food and Drug Administration
Greece: National Organization of Medicines

Keywords provided by National and Kapodistrian University of Athens:
ovarian stimulation
climiphene citrate
Gonadotropin-Releasing Hormone agonists/antagonists
Follicle Stimulating Hormone

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 24, 2016