Use of High Cost Monitoring During Letrozole Ovulation Induction
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Midcycle ultrasound + hCG injection
Urinary LH kits
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring letrozole, ovulation monitoring, pregnancy rate
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).
Sites / Locations
- Center for Reproductive Medicine, University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Urinary LH Kits
Midcycle ultrasound + hCG injection
Arm Description
Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).
Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.
Outcomes
Primary Outcome Measures
Pregnancy Success Rate
Percentage of women in each arm who became pregnant within the study time frame.
Secondary Outcome Measures
Time to Conception, Measured in Cycles
Cycles means treatment/menstrual cycles, approximately 28-33 days.
Full Information
NCT ID
NCT01279200
First Posted
January 18, 2011
Last Updated
January 5, 2015
Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield of Michigan Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01279200
Brief Title
Use of High Cost Monitoring During Letrozole Ovulation Induction
Official Title
Use of High Cost Monitoring During Letrozole Ovulation Induction and Effect on Pregnancy Rates - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield of Michigan Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
letrozole, ovulation monitoring, pregnancy rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urinary LH Kits
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).
Arm Title
Midcycle ultrasound + hCG injection
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.
Intervention Type
Other
Intervention Name(s)
Midcycle ultrasound + hCG injection
Other Intervention Name(s)
Ovidrel
Intervention Description
Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate.
Intervention Type
Other
Intervention Name(s)
Urinary LH kits
Other Intervention Name(s)
ClearBlue Easy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pregnancy Success Rate
Description
Percentage of women in each arm who became pregnant within the study time frame.
Time Frame
3 menstrual/treatment cycles (approximately 28-33 days each)
Secondary Outcome Measure Information:
Title
Time to Conception, Measured in Cycles
Description
Cycles means treatment/menstrual cycles, approximately 28-33 days.
Time Frame
3 menstrual/treatment cycles, or upon conception, whichever comes first
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senait Fisseha, MD, JD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Reproductive Medicine, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20592587
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.
Results Reference
background
PubMed Identifier
11172831
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. doi: 10.1016/s0015-0282(00)01705-2.
Results Reference
background
PubMed Identifier
15239837
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. doi: 10.1186/1477-7827-2-55.
Results Reference
background
PubMed Identifier
9207582
Citation
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. doi: 10.1016/s0015-0282(97)81473-2.
Results Reference
background
PubMed Identifier
10360912
Citation
Zreik TG, Garcia-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. doi: 10.1016/s0015-0282(99)00116-8.
Results Reference
background
PubMed Identifier
16595218
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. doi: 10.1016/j.fertnstert.2005.07.1331.
Results Reference
background
PubMed Identifier
9660442
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. doi: 10.1016/s0015-0282(98)00119-8.
Results Reference
background
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Use of High Cost Monitoring During Letrozole Ovulation Induction
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