Use of High Cost Monitoring During Letrozole Ovulation Induction

University of Michigan

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Other: Midcycle ultrasound + hCG injection; Other: Urinary LH kits

Study type: Interventional

Funder types: Other

Identifiers

NCT01279200

1726.PIRAP (Other Grant/Funding Number)

HUM00041349

Details and patient eligibility

About

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).

Full 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.

Enrollment: 21 patients

Sex: Female

Ages: 21 to 39 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Urinary LH Kits

Active Comparator group

Description:

Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).

Treatment:

Other: Urinary LH kits

Midcycle ultrasound + hCG injection

Active Comparator group

Description:

Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.

Treatment:

Other: Midcycle ultrasound + hCG injection