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Timing of HCG Administration in IUI Cycles

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ClinicalTrials.gov Identifier: NCT02330705
Recruitment Status : Recruiting
First Posted : January 5, 2015
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Ibrahem Eid, Mansoura University

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.

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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


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




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



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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.

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
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Contact: Mohamed I Eid, Dr +201225401274 dr_moh_eid@yahoo.com

Locations
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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
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Principal Investigator: Mohamed I Eid, Dr Mansoura University

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Responsible Party: Mohamed Ibrahem Eid, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02330705     History of Changes
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:
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Infertility
Genital Diseases, Male
Genital Diseases, Female