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Timing of HCG Administration in IUI Cycles

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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

Tracking Information
First Submitted Date  ICMJE December 31, 2014
First Posted Date  ICMJE January 5, 2015
Last Update Posted Date January 25, 2019
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 1, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Timing of HCG Administration in IUI Cycles
Official Title  ICMJE Timing of Human Chorionic Gonadotropin Administration in Intrauterine Insemination Cycles
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Infertility
Intervention  ICMJE Drug: HCG
Women will be given HCG before IUI
Other Name: Pregnyl
Study Arms  ICMJE
  • Active Comparator: Group A
    IUI at time of HCG
    Intervention: Drug: HCG
  • Active Comparator: Group B
    IUI 12 hours after HCG
    Intervention: Drug: HCG
  • Active Comparator: Group C
    IUI 34-36 hours after HCG
    Intervention: Drug: HCG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 1, 2015)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02330705
Other Study ID Numbers  ICMJE MIE3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mohamed Ibrahem Eid, Mansoura University
Study Sponsor  ICMJE Mohamed Ibrahem Eid
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed I Eid, Dr Mansoura University
PRS Account Mansoura University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP