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Timing and Intrauterine Insemination in Unexplained Infertility

Primary Purpose

Intrauterine Insemination

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
hCG
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intrauterine Insemination focused on measuring infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild male infertility or unexplained infertility

Exclusion Criteria:

  • Adanced male factor endometriosis uterine abnormality sever semen parameters i impairment according to WHO 2010 non ovulatory cycles bilatral tubal block

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    GROUP 1

    GROUP 2

    GROUP 3

    GROUP 4

    Arm Description

    IUI 24 hours after hCGadminstration

    IUI 36 hours after hCG adminstration

    IUI 48 hours after hCG adminstration

    IUI at time of hCG adminstration

    Outcomes

    Primary Outcome Measures

    Primary outcome
    Positive serum beta hCG test
    Secondary outcome
    Clinical pregnancy defined as prescence of at least one Intrauterine gestational sac with fetal pole on Transvaginal scan

    Secondary Outcome Measures

    Full Information

    First Posted
    April 16, 2019
    Last Updated
    April 17, 2019
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03920514
    Brief Title
    Timing and Intrauterine Insemination in Unexplained Infertility
    Official Title
    Different Timing of Intrauterine Insemination and Pregnancy Outcome in Patient With Unexplained Infertility :A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 30, 2019 (Anticipated)
    Primary Completion Date
    September 30, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    to determine the most suitable time for administration of (human chorionic gonadotropin )hCG prior to intrauterine insemination (IUI) to optimize pregnancy outcome and to have the best success rates so the cases divided in to four groups according to the time of hCG administration .
    Detailed Description
    IUI with or without ovarian stimulation is a common treatment for infertility ,it is a simple procedure the semen is prepared in the laboratory and transferred by a catheter and injected intrauterine .ultrasound folliculometry is used for monitoring follicular growth where some clinicians prefer the natural cycles and others prefer ovarian stimulation and human chorionic gonadotropin (hCG)trigger for better timing .so cases will take induction and folliculometry will be done until the follicle reach 18mm trigger with hCG .women will be randomly divided to four groups .the first group will undergo IUI at 24 after trigger the second IUI at36 hour after trigger the thirdG at 48 after trigger and finaly the last group IUI will be done simultaneos with trigger the out come the number of pregnant women for each group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intrauterine Insemination
    Keywords
    infertility

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Women will be randomly divided in to four groups the first Group will undergo IUI after 24 H of hCG administration the second g will undergo IUI after 36 h after hCG the third Group will undergo IUI after 48h of hCG administration the last Group will undergo IUI at the time of hCG adminstration
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GROUP 1
    Arm Type
    Active Comparator
    Arm Description
    IUI 24 hours after hCGadminstration
    Arm Title
    GROUP 2
    Arm Type
    Active Comparator
    Arm Description
    IUI 36 hours after hCG adminstration
    Arm Title
    GROUP 3
    Arm Type
    Active Comparator
    Arm Description
    IUI 48 hours after hCG adminstration
    Arm Title
    GROUP 4
    Arm Type
    Active Comparator
    Arm Description
    IUI at time of hCG adminstration
    Intervention Type
    Drug
    Intervention Name(s)
    hCG
    Other Intervention Name(s)
    Pregnyl
    Intervention Description
    Women will be given hCG before or with IUI
    Primary Outcome Measure Information:
    Title
    Primary outcome
    Description
    Positive serum beta hCG test
    Time Frame
    14 days after IUI
    Title
    Secondary outcome
    Description
    Clinical pregnancy defined as prescence of at least one Intrauterine gestational sac with fetal pole on Transvaginal scan
    Time Frame
    4 weeks after insemination

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mild male infertility or unexplained infertility Exclusion Criteria: Adanced male factor endometriosis uterine abnormality sever semen parameters i impairment according to WHO 2010 non ovulatory cycles bilatral tubal block
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Salwa Sabry Ahmed, Candidate
    Phone
    +201022616301
    Email
    drsalwasabry@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Sabry Ebrahim, Lecture of obs and gyn
    Phone
    +201096254975
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Allam Mohamed Abd elmonam, Professor of obs and gyn
    Organizational Affiliation
    Faculty of medicine sohag university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23932307
    Citation
    Aydin Y, Hassa H, Oge T, Tokgoz VY. A randomized study of simultaneous hCG administration with intrauterine insemination in stimulated cycles. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):444-8. doi: 10.1016/j.ejogrb.2013.07.022. Epub 2013 Aug 6.
    Results Reference
    background
    PubMed Identifier
    25528596
    Citation
    Cantineau AE, Janssen MJ, Cohlen BJ, Allersma T. Synchronised approach for intrauterine insemination in subfertile couples. Cochrane Database Syst Rev. 2014 Dec 21;(12):CD006942. doi: 10.1002/14651858.CD006942.pub3.
    Results Reference
    background
    PubMed Identifier
    27686502
    Citation
    Yumusak OH, Kahyaoglu S, Pekcan MK, Isci E, Cinar M, Tasci Y. Does intrauterine insemination timing matter for achieving pregnancy during ovulation induction using gonadotropins? A retrospective cohort study. J Chin Med Assoc. 2017 Jun;80(6):366-370. doi: 10.1016/j.jcma.2016.06.005. Epub 2016 Sep 27.
    Results Reference
    background

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    Timing and Intrauterine Insemination in Unexplained Infertility

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