Use of High Cost Monitoring During Letrozole Ovulation Induction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of High Cost Monitoring During Letrozole Ovulation Induction and Effect on Pregnancy Rates - A Pilot Study

Conditions
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Infertility

Intervention / Treatment
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* Other: Midcycle ultrasound + hCG injection
* Other: Urinary LH kits


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Urinary LH Kits<br>Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's). | Other: Urinary LH kits<br>* 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.<br>* Other names: ClearBlue Easy;|
| Active Comparator: Midcycle ultrasound + hCG injection<br>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<br>* Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate.<br>* Other names: Ovidrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Success Rate | Percentage of women in each arm who became pregnant within the study time frame. | 3 menstrual/treatment cycles (approximately 28-33 days each) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Conception, Measured in Cycles | Cycles means treatment/menstrual cycles, approximately 28-33 days. | 3 menstrual/treatment cycles, or upon conception, whichever comes first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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letrozole, ovulation monitoring, pregnancy rate