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

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

Study Overview

• Status: Unknown
• Conditions: Intracytoplasmic Sperm Injection ,Hysteroscopicaly Detected Cervical Pathologies
• Intervention / Treatment: Procedure: Office Hysteroscopy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Ahmed M. Kamel, MSc&MBBH; Phone Number: 002 01003627020; Email: ahmedmomen414@yahoo.com
• Study Contact Backup: Name: Ibrahim I. Mohammed, MD&MSC; Phone Number: 002 01001027715; Email: ibraheem_hendy@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Recruiting
    • Faculty of Medicine, Women Health Hospital, Assiut University, Egypt
    • Contact: Abdalla H Mohamed; Phone Number: +201002621430; Email: abdalla82eg@gmail.com
    • Contact: Ashraf M Desouky, Eng; Phone Number: +201009342556; Email: ashrafmdesouky@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All infertile women will be assessed in IVF&ICSI unite of Women Health hospital,Assiut university and will be recruted according to the inclusion criteria.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group A; women with normal uterine cavity and normal cervix by office hysteroscopy.	Procedure: 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.
group B; women with normal uterine cavity with hysteroscopically detected cervical abnormality.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	clinical pregnancy rate will be described	7thweek of prgnancy for cardiac pulsations

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemical pregnancy rate	chemical pregnancy rate will be described	4 weeks
Abortion rate	Abortion rate either first or second trimester abortion will be documented.	up to 28 weeks
preterm labour	preterm labour will be described	9 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): October 30, 2020

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: pearlstudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No