Combining LHu With Ultrasound Monitoring in IUI

Ovo Clinic

Status: Terminated

Conditions: Infertility

Treatments: Device: urine LH testing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01205555

F-GYN-10-02

Details and patient eligibility

About

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.

Enrollment: 367 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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367 participants in 2 patient groups

ultrasound alone group

No Intervention group

Description:

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 group

Treatment:

Device: urine LH testing