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Use of High Cost Monitoring During Letrozole Ovulation Induction

This study has been completed.
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Senait Fisseha, MD, JD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01279200
First received: January 18, 2011
Last updated: January 5, 2015
Last verified: January 2015

January 18, 2011
January 5, 2015
January 2011
March 2013   (final data collection date for primary outcome measure)
Pregnancy Success Rate [ Time Frame: 3 menstrual/treatment cycles (approximately 28-33 days each) ] [ Designated as safety issue: No ]
Percentage of women in each arm who became pregnant within the study time frame.
Pregnancy rate per cycle [ Time Frame: 4 treatment cycles or upon conception ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01279200 on ClinicalTrials.gov Archive Site
Time to Conception, Measured in Cycles [ Time Frame: 3 menstrual/treatment cycles, or upon conception, whichever comes first ] [ Designated as safety issue: No ]
Cycles means treatment/menstrual cycles, approximately 28-33 days.
  • Cost per conception [ Time Frame: 4 cycles or upon conception ] [ Designated as safety issue: No ]
  • Time to conception [ Time Frame: 4 cycles or upon conception ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Use of High Cost Monitoring During Letrozole Ovulation Induction
Use of High Cost Monitoring During Letrozole Ovulation Induction and Effect on Pregnancy Rates - A Pilot Study
The purpose of this study is to investigate monitoring methods during ovulation induction cycles with letrozole and their effect on pregnancy rates. Monitoring ovulation induction cycles with letrozole can be done with a variety of methods, the two most commonly utilized are home-based urinary LH kits (or ovulation predictor kits) and office-based midcycle follicular ultrasound. Letrozole coupled with follicular monitoring by ultrasound may add extra cost per cycle with no improvement in fecundability (pregnancy rates per cycle).
The study will be a randomized controlled trial of adult women with primary and secondary infertility seen at the University of Michigan Health System undergoing ovulation induction (OI) with letrozole as part of their standard clinical care. Patients who are undergoing OI with letrozole as per standard clinical care will be randomized to urinary luteinizing hormone (LH) ovulation predictor kit use versus mid-cycle ultrasound with administration of hCG when appropriate for timing of intercourse or intrauterine insemination. Patients who have been prescribed letrozole as per routine clinical care will be approached to determine willingness to participate in this study. Study period involves up to three ovulation induction cycles or until pregnancy occurs.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
  • Other: Midcycle ultrasound + hCG injection
    Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate.
    Other Name: Ovidrel
  • Other: Urinary LH kits
    Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination.
    Other Name: ClearBlue Easy
  • Active Comparator: Urinary LH Kits
    Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).
    Intervention: Other: Urinary LH kits
  • Active Comparator: Midcycle ultrasound + hCG injection
    Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.
    Intervention: Other: Midcycle ultrasound + hCG injection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women ages 21-39 undergoing letrozole ovulation induction (as part of routine clinical care) at a single academic-infertility center.
  • Normal uterus and evidence of at least tubal patency on one side (as assessed by saline-infusion sonography or hysterosalpingogram per clinical care).

Exclusion Criteria:

  • Current pregnancy
  • Nursing mothers
  • Prior hypersensitivity to hCG preparations
  • Primary ovarian failure or menopausal levels of FSH (>12 mIU/mL)
  • Patients with abnormal uterine bleeding of undetermined origin or ovarian cyst of undetermined origin, sex-hormone dependent tumors, documented bilateral tubal obstruction, uncorrected uterine anomalies,
  • Previous letrozole or gonadotropin use and/or previous treatment with in vitro fertilization
  • Other uncorrected medical condition that would be a contraindication to attempting elective ovulation induction (e.g., uncontrolled diabetes, intracranial lesion, thyroid or adrenal disease).
Female
21 Years to 39 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01279200
HUM00041349, 1726.PIRAP
No
Not Provided
Not Provided
Senait Fisseha, MD, JD, University of Michigan
University of Michigan
Blue Cross Blue Shield of Michigan Foundation
Principal Investigator: Senait Fisseha, MD, JD University of Michigan
University of Michigan
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP