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| ID | Type | Description | Link |
|---|---|---|---|
| 1726.PIRAP | Other Grant/Funding Number | Blue Cross Blue Shield of Michigan Foundation |
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| Name | Class |
|---|---|
| Blue Cross Blue Shield of Michigan Foundation | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urinary LH Kits | Active Comparator | Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's). |
|
| Midcycle ultrasound + hCG injection | Active Comparator | Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midcycle ultrasound + hCG injection | Other | Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senait Fisseha, MD, JD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Reproductive Medicine, University of Michigan | Ann Arbor | Michigan | 48108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20592587 | Background | 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. | |
| 11172831 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Urinary LH Kits | Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's). 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. |
| FG001 | Midcycle Ultrasound + hCG Injection | Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Urinary LH Kits | Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Time to Conception, Measured in Cycles | Cycles means treatment/menstrual cycles, approximately 28-33 days. | Numbers of participants analyzed changes from 8 with kits and 4 with ultrasound (enrolled) because time to conception can be measured only for those who conceived, so the 6 and 1 participants analyzed here are those who were successful in getting pregnant. | Posted | Mean | Full Range | menstrual cycles | 3 menstrual/treatment cycles, or upon conception, whichever comes first |
|
End of Cycle 1, Cycle 2 and Cycle 3; OB ultrasound (if applicable); and at the End of Study visit.
Phone call (group A) or in-person assessment (group B).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Urinary LH Kits | Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's). 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Side effects | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | bone pain, arthralgia |
The original intent was to study 400 women, but due to recruiting and time restraints, final enrollment was only 21. Therefore, statistical analyses of the results were eliminated, as well as some additional outcome measures originally planned for.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senait Fisseha, MD, JD | University of Michigan | 734-763-4323 | sfisseha@med.umich.edu |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C412828 | Ovidrel |
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| Urinary LH kits | Other | 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. |
|
|
| 15239837 | Background | 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. |
| 9207582 | Background | 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. |
| 10360912 | Background | 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. |
| 16595218 | Background | 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. |
| 9660442 | Background | 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. |
| Inconvenience of ultrasound visit |
|
| ultrasound screening failure |
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| Lost to Follow-up |
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| Adverse Event |
|
| BG001 |
| Midcycle Ultrasound + hCG Injection |
Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Gravidity: number of previous pregnancies | Mean | Full Range | pregnancies |
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| Diagnosis of ovulatory dysfunction | Number | participants |
|
| OG001 | Midcycle Ultrasound + hCG Injection | Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle. 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. |
|
|
| Primary | Pregnancy Success Rate | Percentage of women in each arm who became pregnant within the study time frame. | Posted | Number | percentage of participants | 3 menstrual/treatment cycles (approximately 28-33 days each) |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Midcycle Ultrasound + hCG Injection | Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle. 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. | 0 | 11 | 0 | 11 |
|
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