Clinical trial NCT04536389: Pregnancy Rates in Women With Normal Uterine Cavity With and Without Cervical Abnormalities
Official title: Pregnancy Rates in Women With Normal Uterine Cavity With and Without Cervical Abnormalities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracytoplasmic Sperm Injection ,Hysteroscopicaly Detected Cervical Pathologies
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 7thweek of prgnancy for cardiac pulsations
Secondary outcomes:
measure: chemical pregnancy rate
timeFrame: 4 weeks
measure: Abortion rate
timeFrame: up to 28 weeks
measure: preterm labour
timeFrame: 9 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine, Women Health Hospital, Assiut University, Egypt
Study officials:
References:
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. doi: 10.1002/uog.116.
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. doi: 10.7863/jum.2005.24.11.1483.
citation: 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.
citation: 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.