Pregnancy Rates in Women With Normal Uterine Cavity With and Without Cervical Abnormalities

NCT ID: NCT04536389

Last Updated: 2020-09-02

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

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-10-30

Brief Summary

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The aim of our study is to investigate the pregnancy rates in women with normal uterine cavity ,with and without cervical abnormalities.

Detailed Description

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The cervix is made up of the ectocervix and endocervix and is on average 3-4 cm long and 2.5 cm wide (Pardo et al., 2003; Mazouni et al., 2005; Robert et al., 2013). The ectocervix is the portion of the cervix projecting into the vagina. It is composed of non-keratinized stratified squamous epithelium and is divided into anterior and posterior lips. The squamocolumnar junction is the area where the epithelial cells of the endocervix and ectocervix meet (Herfs et al., 2013). In this area, the columnar cells of the endocervix undergo metaplasia to the squamous cells of the ectocervix. The opening of the ectocervix to the vagina is called the external os. Although studies of cervical length in non-pregnant women are few, it is acknowledged that the size and shape of both the cervix and the external os differ in women (Pardo et al., 2003; Mazouni et al., 2005) and vary with age, hormonal changes, parity and surgical treatments to the cervix.

Further evaluation of any cervical abnormalities by hysteroscopy eg. (choronic cervicitis , microcycstic epethelium ,micropolypi , cervical stenosis) before ICSI could address us to a hidden cause of infertility and may improve the pregnancy rates in ICSI cycles with prompt medical or surgical managment of such pathologies.

Conditions

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Intracytoplasmic Sperm Injection ,Hysteroscopicaly Detected Cervical Pathologies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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group A

women with normal uterine cavity and normal cervix by office hysteroscopy.

Office Hysteroscopy

Intervention Type PROCEDURE

The hysteroscope with its light source and flowing fluid was gently introduced into the vagina allowing for gradual distention. Once this was accomplished, the anatomy was followed with delicate movements. The hysteroscope was advanced under vision to the level of the ectocervix, and guided into the endocervical canal. Once the endocervical canal was completely explored, the endoscope was advanced across the internal cervical os to allow evaluation of the panoramic view of the uterine cavity.

hysteroscopic correction of any detected lesion will be scheduled to the endoscopic operative list or the patient will receive the appropriate medical treatment.

group B

women with normal uterine cavity with hysteroscopically detected cervical abnormality.

Office Hysteroscopy

Intervention Type PROCEDURE

The hysteroscope with its light source and flowing fluid was gently introduced into the vagina allowing for gradual distention. Once this was accomplished, the anatomy was followed with delicate movements. The hysteroscope was advanced under vision to the level of the ectocervix, and guided into the endocervical canal. Once the endocervical canal was completely explored, the endoscope was advanced across the internal cervical os to allow evaluation of the panoramic view of the uterine cavity.

hysteroscopic correction of any detected lesion will be scheduled to the endoscopic operative list or the patient will receive the appropriate medical treatment.

Interventions

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Office Hysteroscopy

The hysteroscope with its light source and flowing fluid was gently introduced into the vagina allowing for gradual distention. Once this was accomplished, the anatomy was followed with delicate movements. The hysteroscope was advanced under vision to the level of the ectocervix, and guided into the endocervical canal. Once the endocervical canal was completely explored, the endoscope was advanced across the internal cervical os to allow evaluation of the panoramic view of the uterine cavity.

hysteroscopic correction of any detected lesion will be scheduled to the endoscopic operative list or the patient will receive the appropriate medical treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1\. Women between 18 and 38 years old. 2. An indication for IVF/ICSI. 3. Women with primary or secondary infertility. 4. Women with BMI between 20 \& 35.

Exclusion Criteria

* 1\. Refusal to join the study. 2. Untreated tubal hydrosalpinges. 3. 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

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Momen Ahmed Mohammed Kamel

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, Women Health Hospital, Assiut University, Egypt

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed M. Kamel, MSc&MBBH

Role: CONTACT

01003627020 ext. 002

Ibrahim I. Mohammed, MD&MSC

Role: CONTACT

01001027715 ext. 002

Facility Contacts

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Abdalla H Mohamed

Role: primary

+201002621430

Ashraf M Desouky, Eng

Role: backup

+201009342556

References

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Pardo J, Yogev Y, Ben-Haroush A, Peled Y, Kaplan B, Hod M. Cervical length evaluation by transvaginal sonography in nongravid women with a history of preterm delivery. Ultrasound Obstet Gynecol. 2003 May;21(5):464-6. doi: 10.1002/uog.116.

Reference Type RESULT
PMID: 12768558 (View on PubMed)

Mazouni C, Bretelle F, Blanc K, Heckenroth H, Haddad O, Agostini A, Cravello L, Blanc B, Gamerre M. Transvaginal sonographic evaluation of cervix length after cervical conization. J Ultrasound Med. 2005 Nov;24(11):1483-6. doi: 10.7863/jum.2005.24.11.1483.

Reference Type RESULT
PMID: 16239649 (View on PubMed)

Robert AL, Nicolas F, Lavoue V, Henno S, Mesbah H, Poree P, Leveque J. [Ultrasonographic evaluation of the uterine cervix length remaining after LOOP-excision]. J Gynecol Obstet Biol Reprod (Paris). 2014 Apr;43(4):288-93. doi: 10.1016/j.jgyn.2013.03.014. Epub 2013 Apr 25. French.

Reference Type RESULT
PMID: 23623518 (View on PubMed)

Herfs M, Vargas SO, Yamamoto Y, Howitt BE, Nucci MR, Hornick JL, McKeon FD, Xian W, Crum CP. A novel blueprint for 'top down' differentiation defines the cervical squamocolumnar junction during development, reproductive life, and neoplasia. J Pathol. 2013 Feb;229(3):460-8. doi: 10.1002/path.4110.

Reference Type RESULT
PMID: 23007879 (View on PubMed)

Other Identifiers

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pearlstudy

Identifier Type: -

Identifier Source: org_study_id

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