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NCT02638285 Clinical Trial

Pregnancy Rate by HCG Administration Versus Urinary LH Surge Method in Patients Undergoing IUI

Pregnancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02638285
Other study ID # ShirazSUMSnew
Secondary ID
Status Completed
Phase Phase 4
First received December 16, 2015
Last updated December 18, 2015
Start date January 2009

Study information
Verified date December 2015
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Mashhad University of Medical Sciences
Study type Interventional

Clinical Trial Summary

To compare pregnancy rate by Human Chorionic Gonadotropin (HCG) administration and urinary Luteinizing Hormone (LH) surge method for insemination in patients undergoing Intrauterine Insemination (IUI) at Montaserieh infertility center.

The present study comprised 309 infertile women candidate for IUI, randomly divided into LH surge and HCG groups (assign the number for each patient, odds number for LH and even number for HCG group). All patients were subjected to baseline ultrasound and received clomiphene citrate before undergoing serial transvaginal sonography. LH was measured using LH kit when 2-5 follicles (18-20 mm) appeared in LH surge group, and if positive, IUI was performed after 24 hours. In HCG group, the patients received HCG 1000 units and underwent IUI after 36 hours. The pregnancy rate was then compared in LH and HCG groups.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- infertile women candidate for IUI

Exclusion Criteria:

- women with negative urinary LH surge which required HCG administration,

- those with more than 5 follicles who had to use LH kit and not receive HCG to avoid ovarian hyperstimulation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• LH

• HCG

• Clomiphene

Locations
Country Name City State
Iran, Islamic Republic of Health Policy Research Center Shiraz Fars

Sponsors (1)
Lead Sponsor Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary pregnancy rate Two weeks after IUI Yes
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