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Timing and Intrauterine Insemination in Unexplained Infertility

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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

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 .

Condition or disease Intervention/treatment Phase
Intrauterine Insemination Drug: hCG Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Official Title: Different Timing of Intrauterine Insemination and Pregnancy Outcome in Patient With Unexplained Infertility :A Randomized Controlled Study
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: GROUP 1
IUI 24 hours after hCGadminstration
Drug: hCG
Women will be given hCG before or with IUI
Other Name: Pregnyl

Active Comparator: GROUP 2
IUI 36 hours after hCG adminstration
Drug: hCG
Women will be given hCG before or with IUI
Other Name: Pregnyl

Active Comparator: GROUP 3
IUI 48 hours after hCG adminstration
Drug: hCG
Women will be given hCG before or with IUI
Other Name: Pregnyl

Active Comparator: GROUP 4
IUI at time of hCG adminstration
Drug: hCG
Women will be given hCG before or with IUI
Other Name: Pregnyl




Primary Outcome Measures :
  1. Primary outcome [ Time Frame: 14 days after IUI ]
    Positive serum beta hCG test

  2. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT03920514


Contacts
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Contact: Salwa Sabry Ahmed, Candidate +201022616301 drsalwasabry@yahoo.com
Contact: Mohamed Sabry Ebrahim, Lecture of obs and gyn +201096254975

Sponsors and Collaborators
Sohag University
Investigators
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Principal Investigator: Allam Mohamed Abd elmonam, Professor of obs and gyn Faculty of medicine sohag university

Publications:
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Responsible Party: Salwa Sabry Ahmed Mohamed, Faculty of medicine sohag university, Sohag University
ClinicalTrials.gov Identifier: NCT03920514     History of Changes
Other Study ID Numbers: Intrauterine insemination
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salwa Sabry Ahmed Mohamed, Sohag University:
infertility
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female