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Combining LHu With Ultrasound Monitoring in IUI

NCT01205555 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2017-07-26

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Clinique Ovo

    lead INDUSTRY

Principal Investigators

  • Roland Antaki, MD · ovo fertilité

  • Louise Lapensee, MD · ovo fertilité

  • Isaac Jacques Kadoch, MD · ovo fertilité

  • Nicola Dean, PhD · ovo fertilité

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-15
Primary Completion
2016-08-18
Completion
2016-08-18

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01205555 on ClinicalTrials.gov