Phase 4 N=21 Randomized Treatment

Use of High Cost Monitoring During Letrozole Ovulation Induction

Infertility

Bottom Line

View on ClinicalTrials.gov: NCT01279200 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcome: Primary: Pregnancy Success Rate — 75; 25 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Midcycle ultrasound + hCG injection (Other); Urinary LH kits (Other)
Age: Adult · 21+ yrs
Sex: Female
Sponsor: University of Michigan
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Pregnancy Success Rate	75; 25	—
SECONDARY Time to Conception, Measured in Cycles	1.83; 1	—

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).

Eligibility 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01279200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.