Back to resultsCombining LHu With Ultrasound Monitoring in IUI
Primary Purpose
Infertility
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
urine LH testing
Sponsored by
About this trial
This is an interventional other trial for Infertility focused on measuring intra uterine insemination
Eligibility Criteria
Inclusion Criteria:
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
Sites / Locations
- Ovo Fertilité
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
ultrasound alone group
LH testing combined with ultrasound monitoring
Arm Description
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.
Outcomes
Primary Outcome Measures
pregnancy rate
as defined by positive urine pregnancy test
Secondary Outcome Measures
rate of positive LH testing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01205555
Brief Title
Combining LHu With Ultrasound Monitoring in IUI
Official Title
Combining Urinary Luteinizing Hormone Testing With Ultrasound Monitoring in Intrauterine Insemination Cycles
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
sufficient participants for analysis
Study Start Date
November 15, 2010 (Actual)
Primary Completion Date
August 18, 2016 (Actual)
Study Completion Date
August 18, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Ovo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
intra uterine insemination
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
367 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ultrasound alone group
Arm Type
No Intervention
Arm Description
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.
Arm Title
LH testing combined with ultrasound monitoring
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
urine LH testing
Other Intervention Name(s)
Conceive Ovulation predictor
Intervention Description
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.
Primary Outcome Measure Information:
Title
pregnancy rate
Description
as defined by positive urine pregnancy test
Time Frame
14 days post IUI
Secondary Outcome Measure Information:
Title
rate of positive LH testing
Time Frame
before hCG administration
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Antaki, MD
Organizational Affiliation
ovo fertilité
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Louise Lapensee, MD
Organizational Affiliation
ovo fertilité
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Isaac Jacques Kadoch, MD
Organizational Affiliation
ovo fertilité
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nicola Dean, PhD
Organizational Affiliation
ovo fertilité
Official's Role
Study Director
Facility Information:
Facility Name
Ovo Fertilité
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2P 2S4
Country
Canada
12. IPD Sharing Statement
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Combining LHu With Ultrasound Monitoring in IUI
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