Phase 4
Completed N=21
Use of High Cost Monitoring During Letrozole Ovulation Induction
Source: ClinicalTrials.gov NCT01279200 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Pregnancy Success Rate — 75; 25 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pregnancy Success Rate |
75; 25 | — |
| SECONDARY Time to Conception, Measured in Cycles |
1.83; 1 | — |
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).
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. Informational only — not medical advice.