Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Timing of HCG Administration in IUI Cycles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02330705
Recruitment Status : Unknown
Verified January 2019 by Mohamed Ibrahem Eid, Mansoura University.
Recruitment status was:  Recruiting
First Posted : January 5, 2015
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Ibrahem Eid, Mansoura University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.

Condition or disease Intervention/treatment Phase
Infertility Drug: HCG Phase 4

Detailed Description:
Women will be randomly divided into 3 groups; the first group will undergo IUI at the time HCG administration, the second group will undergo IUI 12 hours after HCG administration and the third group will undergo IUI 34-36 hours after HCG administration.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Timing of Human Chorionic Gonadotropin Administration in Intrauterine Insemination Cycles
Study Start Date : January 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Group A
IUI at time of HCG
 Drug: HCG
Women will be given HCG before IUI
Other Name: Pregnyl
Active Comparator: Group B
IUI 12 hours after HCG
 Drug: HCG
Women will be given HCG before IUI
Other Name: Pregnyl
Active Comparator: Group C
IUI 34-36 hours after HCG
 Drug: HCG
Women will be given HCG before IUI
Other Name: Pregnyl


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 4-6 weeks after IUI ]
    Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after IUI) divided by the number of IUI cycles


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild male factor infertility or unexplained infertility.

Exclusion Criteria:

  • Advanced male factor infertility.
  • Polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria.
  • Endometriosis.
  • Tubal disease.
  • Uterine abnormalities or myoma.
  • Previous uterine surgery.
  • Metabolic or hormonal abnormalities.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT02330705


Contacts
Layout table for location contacts
Contact: Mohamed I Eid, Dr +201225401274 dr_moh_eid@yahoo.com

Locations
Layout table for location information
Egypt
Fertility care unit (FCU) in Mansoura University Hospitals Recruiting
Mansourah, Dakahlia, Egypt, 35111
Contact: Mohamed I Eid, Dr    +201225401274    dr_moh_eid@yahoo.com   
Private fertility care centers Recruiting
Mansourah, Dakahlia, Egypt
Sponsors and Collaborators
Mohamed Ibrahem Eid
Investigators
Layout table for investigator information
Principal Investigator: Mohamed I Eid, Dr Mansoura University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Mohamed Ibrahem Eid, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02330705    
Other Study ID Numbers: MIE3
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mohamed Ibrahem Eid, Mansoura University:
Intrauterine insemination
IUI
HCG
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs