Infertility Clinical Trial
Official title:
Use of High Cost Monitoring During Letrozole Ovulation Induction and Effect on Pregnancy Rates - A Pilot Study
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 |
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).
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Center for Reproductive Medicine, University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Blue Cross Blue Shield of Michigan Foundation |
United States,
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
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 |
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