Use of High Cost Monitoring During Letrozole Ovulation Induction

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279200
• Other study ID #: HUM00041349
• Secondary ID: 1726.PIRAP
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2011
• Last updated: January 5, 2015
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: January 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Midcycle ultrasound + hCG injection
Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate.
• Urinary LH kits
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.

Locations

Country	Name	City	State
United States	Center for Reproductive Medicine, University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

References & Publications (7)

Deaton JL, Clark RR, Pittaway DE, Herbst P, Bauguess P. Clomiphene citrate ovulation induction in combination with a timed intrauterine insemination: the value of urinary luteinizing hormone versus human chorionic gonadotropin timing. Fertil Steril. 1997 Jul;68(1):43-7. — View Citation

Lewis V, Queenan J Jr, Hoeger K, Stevens J, Guzick DS. Clomiphene citrate monitoring for intrauterine insemination timing: a randomized trial. Fertil Steril. 2006 Feb;85(2):401-6. — View Citation

Mitwally MF, Abdel-Razeq S, Casper RF. Human chorionic gonadotropin administration is associated with high pregnancy rates during ovarian stimulation and timed intercourse or intrauterine insemination. Reprod Biol Endocrinol. 2004 Jul 7;2:55. — View Citation

Mitwally MF, Casper RF. Use of an aromatase inhibitor for induction of ovulation in patients with an inadequate response to clomiphene citrate. Fertil Steril. 2001 Feb;75(2):305-9. — View Citation

Pritts EA. Letrozole for ovulation induction and controlled ovarian hyperstimulation. Curr Opin Obstet Gynecol. 2010 Aug;22(4):289-94. doi: 10.1097/GCO.0b013e32833beebf. Review. — View Citation

Smith YR, Randolph JF Jr, Christman GM, Ansbacher R, Howe DM, Hurd WW. Comparison of low-technology and high-technology monitoring of clomiphene citrate ovulation induction. Fertil Steril. 1998 Jul;70(1):165-8. — View Citation

Zreik TG, García-Velasco JA, Habboosh MS, Olive DL, Arici A. Prospective, randomized, crossover study to evaluate the benefit of human chorionic gonadotropin-timed versus urinary luteinizing hormone-timed intrauterine inseminations in clomiphene citrate-stimulated treatment cycles. Fertil Steril. 1999 Jun;71(6):1070-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No