Combining LHu With Ultrasound Monitoring in IUI

NCT ID: NCT01205555

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 367 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-15
• Study Completion Date: 2016-08-18

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

LH testing combined with ultrasound monitoring

Group Type: EXPERIMENTAL

urine LH testing

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Conceive Ovulation predictor

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinique Ovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland Antaki, MD

Role: PRINCIPAL_INVESTIGATOR

ovo fertilité

Louise Lapensee, MD

Role: STUDY_DIRECTOR

ovo fertilité

Isaac Jacques Kadoch, MD

Role: STUDY_DIRECTOR

ovo fertilité

Nicola Dean, PhD

Role: STUDY_DIRECTOR

ovo fertilité

Locations

Ovo Fertilité

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

F-GYN-10-02

Identifier Type: -

Identifier Source: org_study_id