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Combining LHu With Ultrasound Monitoring in IUI

This study has been terminated.
(sufficient participants for analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01205555
First Posted: September 20, 2010
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
OVO R & D
  Purpose
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.

Condition Intervention
Infertility Device: urine LH testing

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • pregnancy rate [ Time Frame: 14 days post IUI ]
    as defined by positive urine pregnancy test


Secondary Outcome Measures:
  • rate of positive LH testing [ Time Frame: before hCG administration ]

Enrollment: 367
Actual Study Start Date: November 15, 2010
Study Completion Date: August 18, 2016
Primary Completion Date: August 18, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Canada, Quebec
Ovo Fertilité
Montreal, Quebec, Canada, H2P 2S4
Sponsors and Collaborators
OVO R & D
Investigators
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
  More Information

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01205555     History of Changes
Other Study ID Numbers: F-GYN-10-02
First Submitted: September 17, 2010
First Posted: September 20, 2010
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