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RecruitingNCT03824184Updated Sep 26, 2023

Endometrial Assessment of Women With Uterine Infection

An interventional study of manipulation of endometrium in Infertility, sponsored by Aljazeera Hospital. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Aljazeera Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Feb 2019; still recruiting 7 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility .

Read the detailed description

Implantation is the main rate limiting step in IVF outcome. Implantation is described at the cellular and the molecular levels by adhesion or fixation of a good quality embryo to receptive endometrium within a critical period of time, which is called the window of implantation

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 300 is above the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Aljazeera Hospital is the lead sponsor of 64 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women with infertility age from 20-40 years

Exclusion criteria

Exclusion Criteria:

  • Any factor of infertility
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Hysteroscopic evaluation

    Hysteroscopic evaluation Active group : infection Manipulation of endometrium with saline

    Procedure: manipulation of endometrium

  • Other
    control group

    Hysteroscopic evaluation Control group : No infection

    Procedure: manipulation of endometrium

Interventions

  • Proceduremanipulation of endometrium

    Manipulation of endometrium with saline

    Also known as: Saline infusion

06

What researchers measure

Primary outcomes

  1. the number of women who will get pregnant after IUI

    How many women will get pregnant after IUI

    Time frame: within 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Algazeerah and Kasralainy hospital
    Giza, Egypt
    Recruiting
    • Mahmoud Alalfy, master · Contactmahmoudalalfy@ymail.com · +201002611058
    • Ahmed Elgazzar, M.D · Contact+201014005959
    • Mahmoud Alalfy, master · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2019 (actual). Primary completion is estimated for May 2024, 63 months after the start.

Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 63 months is above that.

Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2019
First posted
Jan 31, 2019
StartActual
Feb 2, 2019
Primary completionEst.
May 3, 2024
CompletionEst.
Jun 20, 2024
Last update
Sep 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03824184
Lead sponsor
Aljazeera Hospital
Responsible party
Sponsor
First posted
Jan 31, 2019
Start date
Feb 2, 2019
Primary completion
May 3, 2024 (estimated)
Completion
Jun 20, 2024 (estimated)
Last update
Sep 26, 2023

Study contacts

Mahmoud Alalfy, PhD
Contact
mahmoudalalfy@ymail.com
01002611058
Mahmoud Alalfy
principal investigator · Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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