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Synchronization of Follicle Wave Emergence and Ovarian Stimulation

This study is currently recruiting participants.
Verified by University of Saskatchewan, May 2008

Sponsors and Collaborators: University of Saskatchewan
Royal University Hospital Foundation
Information provided by: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00439829
  Purpose

The objective of the study is to elucidate the effect of synchronizing initiation of ovarian stimulation treatment with follicular wave emergence in poor responder patients undergoing IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.


Condition Intervention Phase
Infertility
 Drug: Gonal F
Drug: Luveris
Drug: Cetrotide
Drug: hCG
 Phase IV

MedlinePlus related topics:   Infertility   

ChemIDplus related topics:   Follitropin beta    Urofollitropin    Choriogonadotropin Alfa    Chorionic gonadotropin    Cetrorelix    Cetrorelix acetate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Synchronization of Follicle Wave Emergence and Ovarian Stimulation in Women With a History of Poor Ovarian Response to Treatment

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • number of follicles greater than or equal to 15 mm on day of hCG [ Time Frame: March 2009 ] [ Designated as safety issue: No ]
  • peak serum estradiol concentrations [ Time Frame: March 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of antral follicles (day 1 or day 4) [ Time Frame: March 2009 ] [ Designated as safety issue: No ]
  • number of follicles aspirated [ Time Frame: March 2009 ] [ Designated as safety issue: No ]
  • number of oocytes obtained [ Time Frame: March 2009 ] [ Designated as safety issue: No ]
  • oocyte morphology [ Time Frame: March 2009 ] [ Designated as safety issue: No ]
  • fertilization rates [ Time Frame: March 2009 ] [ Designated as safety issue: No ]
  • number of viable embryos (day 3 and day 5) [ Time Frame: March 2009 ] [ Designated as safety issue: No ]
  • blastocyst rate [ Time Frame: March 2009 ] [ Designated as safety issue: No ]
  • number of embryos transferred [ Time Frame: March 2009 ] [ Designated as safety issue: No ]
  • clinical pregnancy rate (serum ß-hCG) [ Time Frame: March 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:   80
Study Start Date:   February 2007
Estimated Study Completion Date:   March 2009
Estimated Primary Completion Date:   March 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Initiation of ovarian stimulation therapy on day 1 (i.e., first day of menses)
Drug: Gonal F
  • 450 IU Gonal-f (Serono Canada) subcutaneously daily (225 IU BID; injections to be given after bloodwork).
  • Dosing to begin on day 1 or day 4 (day 1=first day of menses), continuing until administration of human Chorionic Gonadotropin (hCG; see below).
  • Gonal-f dose may be further reduced, at the discretion of the study physician, to minimize the risk of OHSS.
Drug: Luveris

  • 0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met:

    • leading follicle is > 13 mm in diameter
    • if 6 or more follicles develop to > 10 mm and E2 > 1000 pmol/L
  • Dosing to continue until administration of hCG (see below).
Drug: Cetrotide

  • 0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met:

    • leading follicle is > 13 mm in diameter
    • if 6 or more follicles develop to > 10 mm and E2 > 1000 pmol/L
  • Dosing to continue until administration of hCG (see below).
Drug: hCG

- 10,000 IU hCG (Pharmaceutical Partners of Canada Inc.) subcutaneously when:

o > 3 follicles are > 17 mm in diameter
2: Active Comparator
Initiation of ovarian stimulation therapy on day 4 (day 1= first day of menses)
Drug: Gonal F
  • 450 IU Gonal-f (Serono Canada) subcutaneously daily (225 IU BID; injections to be given after bloodwork).
  • Dosing to begin on day 1 or day 4 (day 1=first day of menses), continuing until administration of human Chorionic Gonadotropin (hCG; see below).
  • Gonal-f dose may be further reduced, at the discretion of the study physician, to minimize the risk of OHSS.
Drug: Luveris

  • 0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met:

    • leading follicle is > 13 mm in diameter
    • if 6 or more follicles develop to > 10 mm and E2 > 1000 pmol/L
  • Dosing to continue until administration of hCG (see below).
Drug: Cetrotide

  • 0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met:

    • leading follicle is > 13 mm in diameter
    • if 6 or more follicles develop to > 10 mm and E2 > 1000 pmol/L
  • Dosing to continue until administration of hCG (see below).
Drug: hCG

- 10,000 IU hCG (Pharmaceutical Partners of Canada Inc.) subcutaneously when:

o > 3 follicles are > 17 mm in diameter

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Informed consent obtained
  • Age of 43 years or younger
  • 18 < BMI < 35

  • History of poor response to ovarian stimulation as determined by:

    • previously cancelled oocyte retrieval procedure due to < 4 follicles greater than 12 mm on ultrasound OR
    • < 3 mature oocytes
  • Physical exam performed within the past 12 months
  • Normal or corrected levels of TSH and Prolactin within the past 12 months
  • Has not taken ovarian suppression therapy within 1 month of initiating study drug

Exclusion Criteria:

  • Chronic medical conditions such as renal failure
  • Documented ovarian failure
  • Presence of only one ovary
  • Serum Day 3 FSH > 12 IU/L within the past 6 months
  • Ovaries inaccessible transvaginally
  • Concomitant glucocorticoid use
  • Ongoing pregnancy
  • Any contraindications to ovarian stimulation treatment
  • Participation in an investigational drug trial in the 30 days prior to the pre-study visit
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439829

Contacts
Contact: Angela R Baerwald, PhD     306-966-8073     angela.baerwald@usask.ca    

Locations
Canada, British Columbia
Genesis Fertility Centre     Recruiting
      Vancouver, British Columbia, Canada, V5Z 3X7
      Contact: Margo Fluker, MD FRCSC     1-800-753-0111     fluker@genesis-fertility.com    
      Contact: Stephanie Fisher, MD FRCSC     1-800-753-0111     fisher@genesis-fertility.com    
      Sub-Investigator: Margo Fluker, MD FRCSC            
      Sub-Investigator: Stephanie Fisher, MD FRCSC            
Canada, Saskatchewan
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan     Recruiting
      Saskatoon, Saskatchewan, Canada, S7N0W8
      Sub-Investigator: Angela R Baerwald, PhD CCRP            
      Principal Investigator: Allison M Case, MD FRCSC            

Sponsors and Collaborators
University of Saskatchewan
Royal University Hospital Foundation

Investigators
Study Director:     Angela R Baerwald, PhD     Dept OB/GYN, University of Saskatchewan    
Principal Investigator:     Allison M Case, MD FRCSC     Dept OB/GYN, University of Saskatchewan    
  More Information

Publications:
Baerwald AR, Adams GP, Pierson RA. A new model for ovarian follicular development during the human menstrual cycle. Fertil Steril. 2003 Jul;80(1):116-22.
 
Baerwald AR, Adams GP, Pierson RA. Characterization of ovarian follicular wave dynamics in women. Biol Reprod. 2003 Sep;69(3):1023-31. Epub 2003 May 14.
 

Responsible Party:   Reproductive Biology Research Unit, Dept OB/GYN, University of Saskatchewan ( Angela Baerwald - Scientific Investigator )
Study ID Numbers:   BIO-REB 06-03, HlthCanadaFile#9427-U0208-47C
First Received:   February 13, 2007
Last Updated:   May 12, 2008
ClinicalTrials.gov Identifier:   NCT00439829
Health Authority:   Canada: Health Canada

Keywords provided by University of Saskatchewan:
follicle  
ovary  
poor responder  
stimulation  
follicle wave emergence  

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Cetrorelix
Chorionic Gonadotropin
Genital Diseases, Male

Additional relevant MeSH terms:
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008

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