Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Timing and Intrauterine Insemination in Unexplained Infertility

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920514
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Salwa Sabry Ahmed Mohamed, Sohag University

Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date April 19, 2019
Estimated Study Start Date  ICMJE April 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Primary outcome [ Time Frame: 14 days after IUI ]
    Positive serum beta hCG test
  • Secondary outcome [ Time Frame: 4 weeks after insemination ]
    Clinical pregnancy defined as prescence of at least one Intrauterine gestational sac with fetal pole on Transvaginal scan
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
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 and Intrauterine Insemination in Unexplained Infertility
Official Title  ICMJE Different Timing of Intrauterine Insemination and Pregnancy Outcome in Patient With Unexplained Infertility :A Randomized Controlled Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Intrauterine Insemination
Intervention  ICMJE Drug: hCG
Women will be given hCG before or with IUI
Other Name: Pregnyl
Study Arms  ICMJE
  • Active Comparator: GROUP 1
    IUI 24 hours after hCGadminstration
    Intervention: Drug: hCG
  • Active Comparator: GROUP 2
    IUI 36 hours after hCG adminstration
    Intervention: Drug: hCG
  • Active Comparator: GROUP 3
    IUI 48 hours after hCG adminstration
    Intervention: Drug: hCG
  • Active Comparator: GROUP 4
    IUI at time of hCG adminstration
    Intervention: Drug: hCG
Publications *

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Salwa Sabry Ahmed, Candidate +201022616301 drsalwasabry@yahoo.com
Contact: Mohamed Sabry Ebrahim, Lecture of obs and gyn +201096254975
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920514
Other Study ID Numbers  ICMJE Intrauterine insemination
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Salwa Sabry Ahmed Mohamed, Sohag University
Study Sponsor  ICMJE Sohag University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Allam Mohamed Abd elmonam, Professor of obs and gyn Faculty of medicine sohag university
PRS Account Sohag University
Verification Date April 2019

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