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

IVF Clinical Trial

Official title:

Association Between Uterine , Intracavitary , Cervical and Cervical Canal Lesions With in Vitro Fertilization/Intracytoplasmic Sperm Injection(IVF/ICSI) Outcome.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04939376
• Other study ID #: Uterine lesions and ICSI
• Status: Not yet recruiting
• Start date: July 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: June 2021
• Source: Assiut University
• Contact: Khaled Mostafa, Rsedent.dr
• Phone: 0201140465869
• Email: khaledmostafa849[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 122
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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).

Related Conditions & MeSH terms

• IVF

Intervention

Procedure:
• IVF
In vitro fertilization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View Citation

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. Review. — View Citation

Rai R, Regan L. Recurrent miscarriage. Lancet. 2006 Aug 12;368(9535):601-11. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	Pregnancy rate with IVF/ICSI with uterine lesions	Baseline