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Status unknownNCT04939376Updated Jun 30, 2021

Uterine Lesions and Their Association to Invitro Fertilization(IVF) or Intracytoplasmic Sperm Injection(ICSI) Outcome

An observational study in IVF, sponsored by Assiut University. Status unknown. Open to female participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-30.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
122
Ages
18 Years to 38 Years
Sex
Female
01

Study summary

  1. To study the effect of uterine wall , intracavitary , cervical as well as cervical canal lesion on the outcome of IVF/ICSI cycle.
  2. To establish a score for prediction of IVF/ICSI cycle success .
Read the detailed description

IVF is one of the most successful treatment of fertility, (1) however, several IVF cycles fail to achieve pregnancy (2).failure defined as three or more failed attempts of ICSI (3). Implantation failure is a complex in nature, may be due to structural or functional causes (3, 4).

that previously undiagnosed, misinterpreted initial diagnoses, or subtle newly added intrauterine abnormalities may be a significant cause of IVF failure (5, 6), studies say that intra-uterine pathologies represent 40-50 % of causes of ICSI failure (7, 8), hysteroscopic removal of endometrial polyps, submucous fibroids, uterine septum, or intrauterine adhesions could increase the pregnancy rate (9). so, Evaluation of the uterine cavity may become a routine investigation before assisted reproductive technology(ART) procedures (10).

In this study, we evaluate the relationship between the different uterine and cervical pathologies and decreased live birth rate.

02

Conditions studied

  • IVF
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women between 18 and 38 years old.

  • An indication for IVF/ICSI..
  • Women with BMI between 18.5 : 29.9 .

Inclusion criteria

  • Women between 18 and 38 years old.

    • An indication for IVF/ICSI..
    • Women with BMI between 18.5 : 29.9 .
    • Women with normal antimullerian hormone(AMH), antral follicle count(AFC) (good responders).

Exclusion criteria

Exclusion Criteria:

Refusal to join the study.

  • Women with age less than 18 and more than 38 .
  • Women with BMI less than 18.5 and more than 30 .
  • Untreated tubal hydrosalpinges.
  • Poor responders as assessed by AFC 4 or less ,AMH O.8 ng/dl (nice 2013).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
122 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group A

    Women with hysteroscopically or ultrasonographic detected uterine anomalies(adenomyosis,fibroid) intracavitary lesions ( like polyp, adhesion or septum) and those with detected endometrial abnormalities (like hypervascularization,pale endometrium) ,cervical lesion and cervical canal lesion or pelvic lesion

    Procedure: IVF

  • Group B

    Matched women (eg. Age,parity, BMI, ovarian reserve....) with no uterine or ovarian abnormalities assessed by hysteroscopy or ultrasonography.

    Procedure: IVF

Interventions

  • ProcedureIVF

    In vitro fertilization

06

What researchers measure

Primary outcomes

  1. Pregnancy rate

    Pregnancy rate with IVF/ICSI with uterine lesions

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Rai R, Regan L. Recurrent miscarriage. Lancet. 2006 Aug 12;368(9535):601-11. doi: 10.1016/S0140-6736(06)69204-0. PubMed 16905025 ↗
  • Dicker D, Ashkenazi J, Feldberg D, Farhi J, Shalev J, Ben-Rafael Z. The value of repeat hysteroscopic evaluation in patients with failed in vitro fertilization transfer cycles. Fertil Steril. 1992 Oct;58(4):833-5. doi: 10.1016/s0015-0282(16)55338-2. PubMed 1426335 ↗
  • Levi Setti PE, Colombo GV, Savasi V, Bulletti C, Albani E, Ferrazzi E. Implantation failure in assisted reproduction technology and a critical approach to treatment. Ann N Y Acad Sci. 2004 Dec;1034:184-99. doi: 10.1196/annals.1335.021. PubMed 15731311 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04939376
Lead sponsor
Assiut University
Responsible party
Khaled Mostafa Ahmed (doctor, Assiut University) — Principal investigator
First posted
Jun 25, 2021
Start date
Jul 1, 2021 (estimated)
Primary completion
Mar 1, 2024 (estimated)
Completion
Apr 1, 2024 (estimated)
Last update
Jun 30, 2021

Study contacts

Khaled Mostafa, Rsedent.dr
Contact
khaledmostafa849@yahoo.com
0201140465869
Momen Kamel, Prof.dr
Contact
Momen_k2000@yahoo.com
0201000328901
Momen Kamel, Prof.dr
study director · Assiut 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 Jun 2021. You cannot join it, but the record below documents what was studied.

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