Trial Outcomes & Findings for Use of High Cost Monitoring During Letrozole Ovulation Induction (NCT NCT01279200)
NCT ID: NCT01279200
Last Updated: 2015-01-06
Results Overview
Percentage of women in each arm who became pregnant within the study time frame.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
3 menstrual/treatment cycles (approximately 28-33 days each)
Results posted on
2015-01-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Patient withdrawal due to high cost
|
0
|
1
|
|
Overall Study
Inconvenience of ultrasound visit
|
0
|
1
|
|
Overall Study
ultrasound screening failure
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Use of High Cost Monitoring During Letrozole Ovulation Induction
Baseline characteristics by cohort
| Measure |
Urinary LH Kits
n=10 Participants
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.
|
Midcycle Ultrasound + hCG Injection
n=11 Participants
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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.7 years
n=5 Participants
|
29.8 years
n=7 Participants
|
29.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gravidity: number of previous pregnancies
|
.7 pregnancies
n=5 Participants
|
1.1 pregnancies
n=7 Participants
|
.9 pregnancies
n=5 Participants
|
|
Diagnosis of ovulatory dysfunction
prior diagnosis of ovulatory dysfunction
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Diagnosis of ovulatory dysfunction
no prior diagnosis of ovulatory dysfunction
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 menstrual/treatment cycles (approximately 28-33 days each)Percentage of women in each arm who became pregnant within the study time frame.
Outcome measures
| Measure |
Urinary LH Kits
n=8 Participants
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.
|
Midcycle Ultrasound + hCG Injection
n=4 Participants
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.
|
|---|---|---|
|
Pregnancy Success Rate
|
75 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: 3 menstrual/treatment cycles, or upon conception, whichever comes firstPopulation: 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.
Cycles means treatment/menstrual cycles, approximately 28-33 days.
Outcome measures
| Measure |
Urinary LH Kits
n=6 Participants
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.
|
Midcycle Ultrasound + hCG Injection
n=1 Participants
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.
|
|---|---|---|
|
Time to Conception, Measured in Cycles
|
1.83 menstrual cycles
Interval 1.0 to 3.0
|
1 menstrual cycles
Interval 1.0 to 1.0
|
Adverse Events
Urinary LH Kits
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Midcycle Ultrasound + hCG Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Urinary LH Kits
n=10 participants at risk
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.
|
Midcycle Ultrasound + hCG Injection
n=11 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Side effects
|
10.0%
1/10 • Number of events 1 • 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).
|
0.00%
0/11 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place