InfertilityNCT01205555
Combining LHu With Ultrasound Monitoring in IUI
A study testing urine LH testing in people with Infertility, run by Clinique Ovo at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- urine LH testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2010to 18 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combining Urinary Luteinizing Hormone Testing With Ultrasound Monitoring in Intrauterine Insemination Cycles
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.
- Conditions
- Infertility
- Being tested
- urine LH testing
- Keywords
- intra uterine insemination
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine LH testingDevice
Also called Conceive Ovulation predictor
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described Receives: Device: urine LH testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
as defined by positive urine pregnancy test
Measured: 14 days post IUI
Secondary outcomes (1)
rate of positive LH testing
Measured: before hCG administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study start15 Nov 2010
- Primary completion18 Aug 2016
- Study completion18 Aug 2016
Why it stopped: sufficient participants for analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roland Antaki, MD, Principal investigator, ovo fertilitéLouise Lapensee, MD, Study director, ovo fertilitéIsaac Jacques Kadoch, MD, Study director, ovo fertilitéNicola Dean, PhD, Study director, ovo fertilité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205555
- Sponsor's protocol ID
- F-GYN-10-02
- Status last verified
- Jul 2017
- First submitted
- 17 Sep 2010
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Urinary Luteinizing Hormone Testing With Ultrasound Monitoring in Intrauterine Insemination Cycles
- ClinicalTrials.gov ID
- NCT01205555
- Acronym / sponsor ID
- F-GYN-10-02
- Conditions
- Infertility
- Keywords
- intra uterine insemination
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sufficient participants for analysis
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2010 (actual)
- Primary completion
- 18 Aug 2016 (actual)
- Study completion
- 18 Aug 2016 (actual)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: urine LH testing |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine LH testingAlso: Conceive Ovulation predictorThe 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. | Device | LH testing combined with ultrasound monitoring |
Primary outcome
pregnancy rate
Time frame: 14 days post IUI
as defined by positive urine pregnancy test
1 secondary outcome
rate of positive LH testing
Time frame: before hCG administration
Results and safety
The study was stopped early (reason given: sufficient participants for analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Antaki, MD principal investigator
ovo fertilité
Louise Lapensee, MD study director
ovo fertilité
Isaac Jacques Kadoch, MD study director
ovo fertilité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urine LH testing in people with Infertility, run by Clinique Ovo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: sufficient participants for analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: 14 days post IUI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.