Combining LHu With Ultrasound Monitoring in IUI
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ClinicalTrials.gov Identifier: NCT01205555 |
Recruitment Status
:
Terminated
(sufficient participants for analysis)
First Posted
: September 20, 2010
Last Update Posted
: July 26, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infertility | Device: urine LH testing | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 367 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Combining Urinary Luteinizing Hormone Testing With Ultrasound Monitoring in Intrauterine Insemination Cycles |
Actual Study Start Date : | November 15, 2010 |
Actual Primary Completion Date : | August 18, 2016 |
Actual Study Completion Date : | August 18, 2016 |
Arm | Intervention/treatment |
---|---|
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.
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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
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- pregnancy rate [ Time Frame: 14 days post IUI ]as defined by positive urine pregnancy test
- rate of positive LH testing [ Time Frame: before hCG administration ]

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Ages Eligible for Study: | 18 Years to 39 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Undergoing IUI treatments for:
- Unexplained infertility (including endometriosis stage 1-2)
- Mild male factor (>5x106/ml motile sperm as determined by total sperm concentration x % A+B motility in the latest spermogram)
- Donor insemination
- 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:
- Polycystic ovarian syndrome or any cause of oligo or anovulation
- Patients taking other infertility medication (metformin, 17B estradiol, progesterone or gonadotropins)
- Presence of an ovarian cyst or a follicle >20 mm on the first ultrasound or any reason for immediate HCG administration
- A previous sperm washing result with less than 5x106/ml motile sperm
- Previous inconclusive uLH test or inability to perform uLH testing

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205555
Canada, Quebec | |
Ovo Fertilité | |
Montreal, Quebec, Canada, H2P 2S4 |
Principal Investigator: | Roland Antaki, MD | ovo fertilité | |
Study Director: | Louise Lapensee, MD | ovo fertilité | |
Study Director: | Isaac Jacques Kadoch, MD | ovo fertilité | |
Study Director: | Nicola Dean, PhD | ovo fertilité |
Responsible Party: | OVO R & D |
ClinicalTrials.gov Identifier: | NCT01205555 History of Changes |
Other Study ID Numbers: |
F-GYN-10-02 |
First Posted: | September 20, 2010 Key Record Dates |
Last Update Posted: | July 26, 2017 |
Last Verified: | July 2017 |
Keywords provided by OVO R & D:
intra uterine insemination |
Additional relevant MeSH terms:
Infertility Genital Diseases, Male Genital Diseases, Female |