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sufficient participants for analysis
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrasound alone group | No Intervention | 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. | |
| LH testing combined with ultrasound monitoring | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| urine LH testing | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy rate | as defined by positive urine pregnancy test | 14 days post IUI |
| Measure | Description | Time Frame |
|---|---|---|
| rate of positive LH testing | before hCG administration |
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Inclusion Criteria:
Undergoing IUI treatments for:
Natural or stimulated cycles with clomiphene citrate or letrozole
At least 1 patent tube on hysterosalpingogram, hysterosonogram or laparoscopy within the last two years
Antral follicular count ≥10 and FSH<10
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roland Antaki, MD | ovo fertilité | Principal Investigator |
| Louise Lapensee, MD | ovo fertilité | Study Director |
| Isaac Jacques Kadoch, MD | ovo fertilité | Study Director |
| Nicola Dean, PhD | ovo fertilité | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ovo Fertilité | Montreal | Quebec | H2P 2S4 | Canada |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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