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Use of High Cost Monitoring During Letrozole Ovulation Induction

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

Condition Intervention Phase
Other: Midcycle ultrasound + hCG injection
Other: Urinary LH kits
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of High Cost Monitoring During Letrozole Ovulation Induction and Effect on Pregnancy Rates - A Pilot Study

Resource links provided by NLM:

Further study details as provided by Senait Fisseha, MD, JD, University of Michigan:

Primary Outcome Measures:
  • Pregnancy Success Rate [ Time Frame: 3 menstrual/treatment cycles (approximately 28-33 days each) ]
    Percentage of women in each arm who became pregnant within the study time frame.

Secondary Outcome Measures:
  • Time to Conception, Measured in Cycles [ Time Frame: 3 menstrual/treatment cycles, or upon conception, whichever comes first ]
    Cycles means treatment/menstrual cycles, approximately 28-33 days.

Enrollment: 21
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Urinary LH Kits
Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).
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: 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.
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

Detailed Description:
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.

Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01279200

United States, Michigan
Center for Reproductive Medicine, University of Michigan
Ann Arbor, Michigan, United States, 48108
Sponsors and Collaborators
University of Michigan
Blue Cross Blue Shield of Michigan Foundation
Principal Investigator: Senait Fisseha, MD, JD University of Michigan
  More Information


Responsible Party: Senait Fisseha, MD, JD, Medical Director, University of Michigan Identifier: NCT01279200     History of Changes
Other Study ID Numbers: HUM00041349
1726.PIRAP ( Other Grant/Funding Number: Blue Cross Blue Shield of Michigan Foundation )
Study First Received: January 18, 2011
Results First Received: December 18, 2014
Last Updated: January 5, 2015

Keywords provided by Senait Fisseha, MD, JD, University of Michigan:
ovulation monitoring
pregnancy rate

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017