NCT02638285

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P25-P50 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

December 16, 2015

Last Update Submit

December 18, 2015

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    Two weeks after IUI

Study Arms (3)

HCG group

EXPERIMENTAL

HCG group

Drug: HCGDrug: Clomiphene

LH group

EXPERIMENTAL

LH group

Drug: LHDrug: Clomiphene

clomiphene citrate

EXPERIMENTAL

clomiphene citrate

Drug: LHDrug: HCG

Interventions

LHDRUG
LH groupclomiphene citrate
HCGDRUG
HCG groupclomiphene citrate
ClomipheneDRUG
HCG groupLH group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • infertile women candidate for IUI

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Policy Research Center

Shiraz, Fars, Iran

Location

MeSH Terms

Interventions

Clomiphene

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Of Pharmacoepidemiology Department, Health policy Research Center,Shiraz university of Medical Sciences

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 23, 2015

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Last Updated

December 23, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will share

Locations

IR(1)