Timing and Intrauterine Insemination in Unexplained Infertility

• ClinicalTrials.gov Identifier: NCT03920514
• Recruitment Status: Not yet recruiting
• First Posted: April 19, 2019
• Last Update Posted: April 19, 2019
• Sponsor: Sohag University
• Information provided by (Responsible Party): Salwa Sabry Ahmed Mohamed, Sohag University

Tracking Information

• First Submitted Date: April 16, 2019
• First Posted Date: April 19, 2019
• Last Update Posted Date: April 19, 2019
• Estimated Study Start Date: April 30, 2019
• Estimated Primary Completion Date: September 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 4

Study Design

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: Intrauterine Insemination

Intervention

Drug: hCG

Women will be given hCG before or with IUI

Other Name: Pregnyl

Study Arms

• 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 *

• 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.
• 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. Review.
• 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.

Recruitment Information

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

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Salwa Sabry Ahmed, Candidate; +201022616301; drsalwasabry@yahoo.com

Contact: Mohamed Sabry Ebrahim, Lecture of obs and gyn; +201096254975

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03920514
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Salwa Sabry Ahmed Mohamed, Sohag University
• Study Sponsor: Sohag University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Allam Mohamed Abd elmonam, Professor of obs and gyn; Faculty of medicine sohag university

• PRS Account: Sohag University
• Verification Date: April 2019