Combining LHu With Ultrasound Monitoring in IUI
Intra-uterine insemination (IUI), generally in combination with ovarian stimulation, is one of the most commonly used treatments for infertility. Accurate timing of insemination, in order to coincide with ovulation, has an important impact on the success rate. Optimal timing of insemination is achieved either by monitoring follicular growth through serial ultrasound measurements followed by the administration of human chorionic gonadotropin (hCG) or by the detection of urinary luteinizing hormone (LH). However in cycles where follicular growth is monitored there is a possibility of premature LH rise before the administration of hCG, which may affect the outcome of the treatment. The goal of the study is to determine if adding the testing of urine LH in conjunction with ultrasound monitoring leads to an increase in pregnancy rates in IUI cycles when compared to ultrasound monitoring alone.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Combining Urinary Luteinizing Hormone Testing With Ultrasound Monitoring in Intrauterine Insemination Cycles|
- pregnancy rate [ Time Frame: 14 days post IUI ] [ Designated as safety issue: No ]as defined by positive urine pregnancy test
- rate of positive LH testing [ Time Frame: before hCG administration ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
No Intervention: ultrasound alone group
Patients in the control group will have a standard ultrasound monitoring with HCG administered when the leading follicle reaches 18 mm, and IUI 36 h afterward.
|Experimental: LH testing combined with ultrasound monitoring||
Device: urine LH testing
The study group will start urine LH (LHu) testing according to the mean diameter of the leading follicle on ultrasound as per :
13mm or less - Repeat ultrasound scan in 1-2 days 14-17mm - start urine LH testing the evening of the day of the scan 18mm or greater - do one LHu test in the afternoon of the day of the scan before HCG administration Once the patient has commenced LHu testing she will perform 2 tests per day. The tests will be performed at 7am and 7pm. LHu testing will continue until the time of HCG administration or positive uLH.If the LHu result is positive either in the morning or afternoon, the insemination will be the next morning without the administration of exogenous HCG.
If the patient has an inconclusive LHu result, a blood LH test will be taken. If the LH blood test is negative (<8 IU\L) she will continue testing LHu. If the LH blood test is positive (≥ 8 IU\L) the insemination will be the next day.
Other Name: Conceive Ovulation predictor
|Contact: Michael Harnois, M.Sc||1 514 798 2000 ext firstname.lastname@example.org|
|Contact: Cynthia Levesque, M.Sc||514 798 2000 ext email@example.com|
|Montreal, Quebec, Canada, H2P 2S4|
|Contact: Shirley Brugerie, director 514 798-2000 ext 753 firstname.lastname@example.org|
|Principal Investigator: Roland Antaki, MD|
|Sub-Investigator: Louise Lapensee, MD|
|Sub-Investigator: Isaac Jacques Kadoch, MD|
|Sub-Investigator: Nicola Dean, PhD|
|Principal Investigator:||Roland Antaki, MD||OVO R & D|
|Study Director:||Louise Lapensee, MD||OVO R & D|
|Study Director:||Isaac Jacques Kadoch, MD||OVO R & D|
|Study Director:||Nicola Dean, PhD||OVO R & D|