Combining LHu With Ultrasound Monitoring in IUI - Full Text View

Purpose

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.

Condition	Intervention
Infertility	Device: urine LH testing


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Combining Urinary Luteinizing Hormone Testing With Ultrasound Monitoring in Intrauterine Insemination Cycles

Resource links provided by NLM:

MedlinePlus related topics: Infertility Ultrasound Urine and Urination

U.S. FDA Resources

Further study details as provided by OVO R & D:

Primary Outcome Measures:

pregnancy rate [ Time Frame: 14 days post IUI ] [ Designated as safety issue: No ]
as defined by positive urine pregnancy test

Secondary Outcome Measures:

rate of positive LH testing [ Time Frame: before hCG administration ] [ Designated as safety issue: No ]


Estimated Enrollment:	500
Study Start Date:	January 2011
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 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.
Experimental: LH testing combined with ultrasound monitoring	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. Other Name: Conceive Ovulation predictor

Arms

Assigned Interventions

No Intervention: 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.

Experimental: LH testing combined with ultrasound monitoring

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.

Other Name: Conceive Ovulation predictor

Eligibility


Ages Eligible for Study:	18 Years to 39 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205555

Contacts


Contact: Sandra Bisotto, M.Sc	1 514 798 2000 ext 755	s.bisotto@cliniqueovo.com
Contact: Cynthia Levesque, M.Sc	514 798 2000 ext 755	c.levesque@cliniqueovo.com

Locations


Canada, Quebec
Ovo Fertilité	Recruiting
Montreal, Quebec, Canada, H2P 2S4
Contact: Shirley Brugerie, director 514 798-2000 ext 753 s.brugerie@cliniqueovo.com
Contact: Sandra Bisotto, Research assistant 514-798-2000 ext 755 s.bisotto@cliniqueovo.com
Principal Investigator: Roland Antaki, MD
Sub-Investigator: Louise Lapensee, MD
Sub-Investigator: Isaac Jacques Kadoch, MD
Sub-Investigator: Nicola Dean, PhD
Sub-Investigator: Coralie Beauchamp, MD
Sub-Investigator: Joanne Benoît, MD
Sub-Investigator: François Bissonnette, MD
Sub-Investigator: Robert Hemmings, MD
Sub-Investigator: Wael Jamal, MD
Sub-Investigator: Abdelmoula Khaled, MD
Sub-Investigator: Sylvain Ménard, MD
Sub-Investigator: Marie-Hélène Racicot, MD
Sub-Investigator: Camille Sylvestre, MD
Sub-Investigator: Bernard Couturier, MD
Sub-Investigator: Carole Rhéaume, inf.

Sponsors and Collaborators

OVO R & D

Investigators


Principal Investigator:	Roland Antaki, MD	ovo fertilité
Study Director:	Louise Lapensee, MD	ovo fertilité
Study Director:	Isaac Jacques Kadoch, MD	ovo fertilité
Study Director:	Nicola Dean, PhD	ovo fertilité

More Information


Responsible Party:	OVO R & D
ClinicalTrials.gov Identifier:	NCT01205555 History of Changes
Other Study ID Numbers:	F-GYN-10-02
Study First Received:	September 17, 2010
Last Updated:	February 1, 2016
Health Authority:	Canada: Ethics Review Committee

Keywords provided by OVO R & D:


intra uterine insemination

Additional relevant MeSH terms:


Infertility Genital Diseases, Male Genital Diseases, Female

ClinicalTrials.gov processed this record on September 27, 2016