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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04939376
Collaborator
(none)
122
33

Study Details

Study Description

Brief 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 .

Condition or Disease Intervention/Treatment Phase
  • Procedure: IVF

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
122 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Association Between Uterine , Intracavitary , Cervical and Cervical Canal Lesions With in Vitro Fertilization/Intracytoplasmic Sperm Injection(IVF/ICSI) Outcome.
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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
In vitro fertilization

Group B

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

Procedure: IVF
In vitro fertilization

Outcome Measures

Primary Outcome Measures

  1. Pregnancy rate [Baseline]

    Pregnancy rate with IVF/ICSI with uterine lesions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 38 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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:

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Momen Kamel, Prof.dr, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Khaled Mostafa Ahmed, doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT04939376
Other Study ID Numbers:
  • Uterine lesions and ICSI
First Posted:
Jun 25, 2021
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 30, 2021