Use of High Cost Monitoring During Letrozole Ovulation Induction

Phase 4

Completed

• Conditions: Infertility
• Interventions: Other: Midcycle ultrasound + hCG injection; Other: Urinary LH kits

• Registration Number: NCT01279200
• Lead Sponsor: University of Michigan

Brief Summary

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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-12-18
• Status Verified: 2015-01
• Results First Submitted QC: 2015-01-05
• Last Update Submitted: 2015-01-05
• Results First Posted: 2015-01-06
• Last Update Posted: 2015-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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).

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midcycle ultrasound + hCG injection	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.
Urinary LH Kits	Urinary LH kits	Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).

Primary Outcome Measures

Name	Time	Method
Pregnancy Success Rate	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

Name	Time	Method
Time to Conception, Measured in Cycles	3 menstrual/treatment cycles, or upon conception, whichever comes first	Cycles means treatment/menstrual cycles, approximately 28-33 days.

Trial Locations

Locations (1)

Center for Reproductive Medicine, University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States