CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Midcycle ultrasound + hCG injection +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01279200
NCT01279200Phase 4Completed
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Use of High Cost Monitoring During Letrozole Ovulation Induction and Effect on Pregnancy Rates - A Pilot Study

University of Michigan·interventional·Posted Jan 19, 2011·Updated Jan 6, 2015

In Brief

A Phase 4 clinical trial evaluating Midcycle ultrasound + hCG injection and Urinary LH kits for Infertility. Completed, enrolled 21 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesUnited States
CollaboratorsBlue Cross Blue Shield of Michigan Foundation

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 19, 2011
Enrollment StartJan 1, 2011
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.5 years ago

Interventions

Midcycle ultrasound + hCG injectionother

Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate.

Urinary LH kitsother

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.