Use of High Cost Monitoring During Letrozole Ovulation Induction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01279200|
Recruitment Status : Completed
First Posted : January 19, 2011
Results First Posted : January 6, 2015
Last Update Posted : January 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Other: Midcycle ultrasound + hCG injection Other: Urinary LH kits||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of High Cost Monitoring During Letrozole Ovulation Induction and Effect on Pregnancy Rates - A Pilot Study|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Active Comparator: Urinary LH Kits
Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).
Other: 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.
Other Name: ClearBlue Easy
Active Comparator: 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.
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.
Other Name: Ovidrel
- Pregnancy Success Rate [ Time Frame: 3 menstrual/treatment cycles (approximately 28-33 days each) ]Percentage of women in each arm who became pregnant within the study time frame.
- Time to Conception, Measured in Cycles [ Time Frame: 3 menstrual/treatment cycles, or upon conception, whichever comes first ]Cycles means treatment/menstrual cycles, approximately 28-33 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279200
|United States, Michigan|
|Center for Reproductive Medicine, University of Michigan|
|Ann Arbor, Michigan, United States, 48108|
|Principal Investigator:||Senait Fisseha, MD, JD||University of Michigan|