Use of High Cost Monitoring During Letrozole Ovulation Induction
|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.
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|