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

Intracytoplasmic Sperm Injection ,Hysteroscopicaly Detected Cervical Pathologies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04536389
• Other study ID #: pearlstudy
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: Ahmed M. Kamel, MSc&MBBH
• Phone: 01003627020
• Email: ahmedmomen414[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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).

Related Conditions & MeSH terms

• Congenital Abnormalities
• Intracytoplasmic Sperm Injection ,Hysteroscopicaly Detected Cervical Pathologies

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Women Health Hospital, Assiut University, Egypt	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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 — View Citation

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. — View Citation

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. — View Citation

Robert AL, Nicolas F, Lavoué V, Henno S, Mesbah H, Porée P, Levêque 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate	clinical pregnancy rate will be described	7thweek of prgnancy for cardiac pulsations
Secondary	chemical pregnancy rate	chemical pregnancy rate will be described	4 weeks
Secondary	Abortion rate	Abortion rate either first or second trimester abortion will be documented.	up to 28 weeks
Secondary	preterm labour	preterm labour will be described	9 months