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: June 10, 2014
Last verified: June 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 University of Michigan:

Primary Outcome Measures:
  • Pregnancy rate per cycle [ Time Frame: 3 treatment cycles or upon conception ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost per conception [ Time Frame: 3 cycles or upon conception ] [ Designated as safety issue: No ]
  • Time to conception [ Time Frame: 3 cycles or upon conception ] [ Designated as safety issue: No ]

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: Group A
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: Group B
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.

  Eligibility

Ages Eligible for Study:   21 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT01279200

Locations
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
Investigators
Principal Investigator: Senait Fisseha, MD, JD University of Michigan
  More Information

Publications:

Responsible Party: Senait Fisseha, MD, JD, Medical Director, University of Michigan
ClinicalTrials.gov Identifier: NCT01279200     History of Changes
Other Study ID Numbers: HUM00041349, 1726.PIRAP
Study First Received: January 18, 2011
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
letrozole
ovulation monitoring
pregnancy rate

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014