Combining LHu With Ultrasound Monitoring in IUI

Not Applicable

Terminated

• Conditions: Infertility
• Interventions: Device: urine LH testing

• Registration Number: NCT01205555
• Lead Sponsor: Clinique Ovo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-17
• Study First Posted: 2010-09-20
• Study Start: 2010-11-15
• Primary Completion: 2016-08-18
• Study Completion: 2016-08-18
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 367

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LH testing combined with ultrasound monitoring	urine LH testing	-

Primary Outcome Measures

Name	Time	Method
pregnancy rate	14 days post IUI	as defined by positive urine pregnancy test

Secondary Outcome Measures

Name	Time	Method
rate of positive LH testing	before hCG administration

Trial Locations

Locations (1)

Ovo Fertilité; 🇨🇦 Montreal, Quebec, Canada