Combining LHu With Ultrasound Monitoring in IUI

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.

Study Overview

• Status: Terminated
• Conditions: Infertility
• Intervention / Treatment: Device: urine LH testing

• Study Type: Interventional
• Enrollment (Actual): 367
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2P 2S4
      • Ovo Fertilité

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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 Names: Conceive Ovulation predictor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy rate	as defined by positive urine pregnancy test	14 days post IUI

Secondary Outcome Measures

Outcome Measure	Time Frame
rate of positive LH testing	before hCG administration

Collaborators and Investigators

• Sponsor: Clinique Ovo
• 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

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2010
• Primary Completion (Actual): August 18, 2016
• Study Completion (Actual): August 18, 2016

Study Registration Dates

• First Submitted: September 17, 2010
• First Submitted That Met QC Criteria: September 17, 2010
• First Posted (Estimate): September 20, 2010

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: intra uterine insemination
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: F-GYN-10-02