Combining LHu With Ultrasound Monitoring in IUI

Infertility Clinical Trial

Official title:

Combining Urinary Luteinizing Hormone Testing With Ultrasound Monitoring in Intrauterine Insemination Cycles

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01205555
• Other study ID #: F-GYN-10-02
• Status: Terminated
• Phase: N/A
• First received: September 17, 2010
• Last updated: July 24, 2017
• Start date: November 15, 2010
• Est. completion date: August 18, 2016

Study information

• Verified date: July 2017
• Source: OVO R & D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 367
• Est. completion date: August 18, 2016
• Est. primary completion date: August 18, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
Canada	Ovo Fertilité	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
OVO R & D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rate	as defined by positive urine pregnancy test	14 days post IUI
Secondary	rate of positive LH testing		before hCG administration