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Synchronization of Follicle Wave Emergence and Ovarian Stimulation
This study has been completed.

First Received on February 13, 2007.   Last Updated on May 21, 2010   History of Changes
Sponsor: University of Saskatchewan
Collaborator: 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Synchronization of Follicle Wave Emergence and Ovarian Stimulation in Women With a History of Poor Ovarian Response to Treatment

Resource links provided by NLM:

MedlinePlus related topics: Infertility
Drug Information available for: Cetrorelix Cetrorelix acetate Follitropin beta
U.S. FDA Resources

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
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Active Comparator: 2
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

  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

Locations
Canada, British Columbia
Genesis Fertility Centre
Vancouver, British Columbia, Canada, V5Z 3X7
Canada, Saskatchewan
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N0W8
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: Angela Baerwald - Scientific Investigator, Reproductive Biology Research Unit, Dept OB/GYN, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00439829     History of Changes
Other Study ID Numbers: BIO-REB 06-03, HlthCanadaFile#9427-U0208-47C
Study First Received: February 13, 2007
Last Updated: May 21, 2010
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on February 12, 2012



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