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Combining LHu With Ultrasound Monitoring in IUI

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by OVO R & D
Sponsor:
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01205555
First received: September 17, 2010
Last updated: March 19, 2014
Last verified: March 2014
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Combining Urinary Luteinizing Hormone Testing With Ultrasound Monitoring in Intrauterine Insemination Cycles

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • pregnancy rate [ Time Frame: 14 days post IUI ] [ Designated as safety issue: No ]
    as defined by positive urine pregnancy test


Secondary Outcome Measures:
  • rate of positive LH testing [ Time Frame: before hCG administration ] [ Designated as safety issue: No ]
Estimated Enrollment: 500
Study Start Date: January 2011
Estimated Primary Completion Date: January 2015 (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
Ages Eligible for Study:   18 Years to 39 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205555

Contacts
Contact: Sandra Bisotto, M.Sc 1 514 798 2000 ext 755 s.bisotto@cliniqueovo.com
Contact: Cynthia Levesque, M.Sc 514 798 2000 ext 755 c.levesque@cliniqueovo.com

Locations
Canada, Quebec
Ovo Fertilité Recruiting
Montreal, Quebec, Canada, H2P 2S4
Contact: Shirley Brugerie, director    514 798-2000 ext 753    s.brugerie@cliniqueovo.com   
Contact: Sandra Bisotto, Research assistant    514-798-2000 ext 755    s.bisotto@cliniqueovo.com   
Principal Investigator: Roland Antaki, MD         
Sub-Investigator: Louise Lapensee, MD         
Sub-Investigator: Isaac Jacques Kadoch, MD         
Sub-Investigator: Nicola Dean, PhD         
Sub-Investigator: Coralie Beauchamp, MD         
Sub-Investigator: Joanne Benoît, MD         
Sub-Investigator: François Bissonnette, MD         
Sub-Investigator: Abdelghani El Fakir, MD         
Sub-Investigator: Robert Hemmings, MD         
Sub-Investigator: Wael Jamal, MD         
Sub-Investigator: Abdelmoula Khaled, MD         
Sub-Investigator: Sylvain Ménard, MD         
Sub-Investigator: Marie-Hélène Racicot, MD         
Sub-Investigator: Camille Sylvestre, MD         
Sub-Investigator: Bernard Couturier, MD         
Sub-Investigator: Carole Rhéaume, inf.         
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

No publications provided

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01205555     History of Changes
Other Study ID Numbers: F-GYN-10-02
Study First Received: September 17, 2010
Last Updated: March 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by OVO R & D:
intra uterine insemination

ClinicalTrials.gov processed this record on March 03, 2015