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

• Conditions: IVF

• Registration Number: NCT04939376
• Lead Sponsor: Assiut University

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 .

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 Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Last Update Submitted: 2021-06-26
• Last Update Posted: 2021-06-30
• Study Start: 2021-07-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 122

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	Baseline	Pregnancy rate with IVF/ICSI with uterine lesions