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