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

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:
NCT01319708
First received: March 8, 2011
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

The investigators will examine the balance between IVF success in terms of outcome parameters, including patient discomfort, complications and cost, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number / rate of participants with ongoing pregnancy [ Time Frame: 10 weeks after embryo transfer ] [ Designated as safety issue: No ]
    Presence of fetal heart at ultrasound after 12 weeks of gestation


Secondary Outcome Measures:
  • Number/rate of participants whom the IVF cycle was cancelled [ Time Frame: After the 1st week of ovarian stimulation ] [ Designated as safety issue: No ]
    The rate of cancellation of the IVF cycle / ovarian stimulation before HCG administration

  • 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


Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mild ovarian stimulation 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
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

  Eligibility

Ages Eligible for Study:   25 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • poor responders
  • indication for IVF
  • regular cycling patients
  • BMI 19-29

Exclusion Criteria:

  • contraindication for clomiphene citrate use or to GnRH antagonists
  • BMI > 30
  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: NCT01319708

Contacts
Contact: Charalampos S Siristatidis, Senior Lecturer 6932294994 ext 0030 harrysiri@yahoo.gr

Locations
Greece
3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit Recruiting
Athens, Chaidari, Greece, 12462
Contact: Siristatidis       harrysiri@yahoo.gr   
Sub-Investigator: Charalampos Chrelias, Assistant Professor         
Sub-Investigator: Dimitrios Kassanos, Associate Professor         
Sponsors and Collaborators
National and Kapodistrian University of Athens
  More Information

No publications provided

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 29, 2013
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/antagonists & inhibitors
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014