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Status unknownNCT03920514Updated Apr 19, 2019

Timing and Intrauterine Insemination in Unexplained Infertility

A Phase 4 interventional study of hCG in Intrauterine Insemination, sponsored by Sohag University. Status unknown. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-04-19.

Sponsored by Sohag University · Phase 4, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study 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 .

Read the 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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Conditions studied

  • Intrauterine Insemination

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Keywords

  • infertility
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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 80 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Mild male infertility or unexplained infertility

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    GROUP 1

    IUI 24 hours after hCGadminstration

    Drug: hCG

  • Active comparator
    GROUP 2

    IUI 36 hours after hCG adminstration

    Drug: hCG

  • Active comparator
    GROUP 3

    IUI 48 hours after hCG adminstration

    Drug: hCG

  • Active comparator
    GROUP 4

    IUI at time of hCG adminstration

    Drug: hCG

Interventions

  • DrughCG

    Women will be given hCG before or with IUI

    Also known as: Pregnyl

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What researchers measure

Primary outcomes

  1. Primary outcome

    Positive serum beta hCG test

    Time frame: 14 days after IUI

  2. Secondary outcome

    Clinical pregnancy defined as prescence of at least one Intrauterine gestational sac with fetal pole on Transvaginal scan

    Time frame: 4 weeks after insemination

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 23932307 ↗
  • Cantineau AE, Janssen MJ, Cohlen BJ, Allersma T. Synchronised approach for intrauterine insemination in subfertile couples. Cochrane Database Syst Rev. 2014 Dec 21;2014(12):CD006942. doi: 10.1002/14651858.CD006942.pub3. PubMed 25528596 ↗
  • 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. PubMed 27686502 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03920514
Lead sponsor
Sohag University
Responsible party
Salwa Sabry Ahmed Mohamed (Faculty of medicine sohag university, Sohag University) — Principal investigator
First posted
Apr 19, 2019
Start date
Apr 30, 2019 (estimated)
Primary completion
Sep 30, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Apr 19, 2019

Study contacts

Salwa Sabry Ahmed, Candidate
Contact
drsalwasabry@yahoo.com
+201022616301
Mohamed Sabry Ebrahim, Lecture of obs and gyn
Contact
+201096254975
Allam Mohamed Abd elmonam, Professor of obs and gyn
principal investigator · Faculty of medicine sohag university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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