Combining LHu With Ultrasound Monitoring in IUI

NCT01205555 | Terminated

• 1 other identifier: F-GYN-10-02
• Study Type: interventional
• Target: 367
• Locations: 1 country
• Sites: 1

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

Keywords

intra uterine insemination

Outcome Measures

Primary Outcomes (1)

• pregnancy rate

  as defined by positive urine pregnancy test

  14 days post IUI

Secondary Outcomes (1)

• rate of positive LH testing

  before hCG administration

Study Arms (2)

ultrasound alone group

NO INTERVENTION

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.

LH testing combined with ultrasound monitoring

EXPERIMENTAL

Device: urine LH testing

Interventions

urine LH testing 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.

Also known as: Conceive Ovulation predictor

LH testing combined with ultrasound monitoring

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Ovo: lead

Study Sites (1)

Ovo Fertilité

Montreal, Quebec, H2P 2S4, Canada

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Roland Antaki, MD

  ovo fertilité

  PRINCIPAL INVESTIGATOR

• Louise Lapensee, MD

  ovo fertilité

  STUDY DIRECTOR

• Isaac Jacques Kadoch, MD

  ovo fertilité

  STUDY DIRECTOR

• Nicola Dean, PhD

  ovo fertilité

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 20, 2010
• Study Start: November 15, 2010
• Primary Completion: August 18, 2016
• Study Completion: August 18, 2016
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

CA (1)