Combining LHu With Ultrasound Monitoring in IUI

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Infertility	Device: urine LH testing	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	367 participants
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
Actual Study Start Date :	November 15, 2010
Actual Primary Completion Date :	August 18, 2016
Actual Study Completion Date :	August 18, 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Conceive Ovulation predictor

Outcome Measures

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Primary Outcome Measures :

1. pregnancy rate [ Time Frame: 14 days post IUI ]
   as defined by positive urine pregnancy test

Secondary Outcome Measures :

1. rate of positive LH testing [ Time Frame: before hCG administration ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	OVO R & D
ClinicalTrials.gov Identifier:	NCT01205555 History of Changes
Other Study ID Numbers:	F-GYN-10-02
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