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Use of High Cost Monitoring During Letrozole Ovulation Induction

This study has been completed.
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Senait Fisseha, MD, JD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01279200
First received: January 18, 2011
Last updated: January 5, 2015
Last verified: January 2015
Results First Received: December 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infertility
Interventions: Other: Midcycle ultrasound + hCG injection
Other: Urinary LH kits

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Urinary LH Kits   Midcycle Ultrasound + hCG Injection
STARTED   10   11 
COMPLETED   8   4 
NOT COMPLETED   2   7 
Withdrawal by Subject                1                3 
Patient withdrawal due to high cost                0                1 
Inconvenience of ultrasound visit                0                1 
ultrasound screening failure                0                1 
Lost to Follow-up                0                1 
Adverse Event                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Urinary LH Kits   Midcycle Ultrasound + hCG Injection   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   11   21 
Age 
[Units: Years]
Mean (Full Range)
 28.7 
 (21 to 39) 
 29.8 
 (21 to 39) 
 29.3 
 (21 to 39) 
Gender 
[Units: Participants]
     
Female   10   11   21 
Male   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   1   2   3 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   9   9   18 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Gravidity: number of previous pregnancies 
[Units: Pregnancies]
Mean (Full Range)
 .7 
 (0 to 2) 
 1.1 
 (0 to 4) 
 .9 
 (0 to 4) 
Diagnosis of ovulatory dysfunction 
[Units: Participants]
     
prior diagnosis of ovulatory dysfunction   4   3   7 
no prior diagnosis of ovulatory dysfunction   6   8   14 


  Outcome Measures
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1.  Primary:   Pregnancy Success Rate   [ Time Frame: 3 menstrual/treatment cycles (approximately 28-33 days each) ]

2.  Secondary:   Time to Conception, Measured in Cycles   [ Time Frame: 3 menstrual/treatment cycles, or upon conception, whichever comes first ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senait Fisseha, MD, JD
Organization: University of Michigan
phone: 734-763-4323
e-mail: sfisseha@med.umich.edu


Publications:


Responsible Party: Senait Fisseha, MD, JD, University of Michigan
ClinicalTrials.gov Identifier: NCT01279200     History of Changes
Other Study ID Numbers: HUM00041349
1726.PIRAP ( Other Grant/Funding Number: Blue Cross Blue Shield of Michigan Foundation )
Study First Received: January 18, 2011
Results First Received: December 18, 2014
Last Updated: January 5, 2015
Health Authority: United States: Institutional Review Board