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

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ClinicalTrials.gov Identifier: NCT02638285
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Payam Peymani, Shiraz University of Medical Sciences

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Pregnancy Drug: LH Drug: HCG Drug: Clomiphene Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2009
Actual Primary Completion Date : August 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: HCG group
HCG group
 Drug: HCG
Drug: Clomiphene
Experimental: LH group
LH group
 Drug: LH
Drug: Clomiphene
Experimental: clomiphene citrate
clomiphene citrate
 Drug: LH
Drug: HCG


Outcome Measures
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Primary Outcome Measures :
  1. pregnancy rate [ Time Frame: Two weeks after IUI ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638285


Locations
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Iran, Islamic Republic of
Health Policy Research Center
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
More Information
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Responsible Party: Payam Peymani, Head Of Pharmacoepidemiology Department, Health policy Research Center,Shiraz university of Medical Sciences, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02638285    
Other Study ID Numbers: ShirazSUMSnew
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Clomiphene
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators