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

NCT ID: NCT04939376

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-04-01

Brief Summary

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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

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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.

Conditions

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IVF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

IVF

Intervention Type PROCEDURE

In vitro fertilization

Group B

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

IVF

Intervention Type PROCEDURE

In vitro fertilization

Interventions

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IVF

In vitro fertilization

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Khaled Mostafa Ahmed

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Momen Kamel, Prof.dr

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Khaled Mostafa, Rsedent.dr

Role: CONTACT

Phone: 0201140465869

Email: [email protected]

Momen Kamel, Prof.dr

Role: CONTACT

Phone: 0201000328901

Email: [email protected]

References

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Rai R, Regan L. Recurrent miscarriage. Lancet. 2006 Aug 12;368(9535):601-11. doi: 10.1016/S0140-6736(06)69204-0.

Reference Type BACKGROUND
PMID: 16905025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1426335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15731311 (View on PubMed)

Other Identifiers

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Uterine lesions and ICSI

Identifier Type: -

Identifier Source: org_study_id