Clinical trial NCT05358678: Cesarean Section Scar Niche: The Impact on ART Outcome
Official title: Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section
ART
Keywords: Cesarean Section niche
ART
Lead sponsor: Rahem Fertility Center
Sponsor class: OTHER
Collaborators: name: Zagazig University
First posted: 2022-05-03
Enrollment: 266
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It will be carried out in the department of Obstetrics and Gynecology, Zagazig University and in Rahem fertility center

Brief summary: To evaluate the impact of the presence of cesarean section niche and its characteristics on the outcome of ART cycles.

Detailed description: The incidence of Cesarean section (CS) is increasing worldwide, with a corresponding increase in its associated complications. The well-known complications are infection, hemorrhage, and increased risk of obstetric complications in subsequent pregnancies, like morbidly adherent placenta, cs scar pregnancies and uterine rupture.

In addition, some studies emphasize the effect of cesarean sections on reduced fertility. A meta-analysis reported that a Caesarean section reduces the probability of subsequent pregnancy by 10%, compared with a previous vaginal delivery.

The cesarean section niche is defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of niche is abnormal uterine bleeding. Meanwhile, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility.

The detection of a cesarean section niche depends on the operator and the diagnostic method used. This can be 2D, 3D transvaginal sonography, sonohysterography or hysteroscopy.

Regarding ART, the presence of cs niche was reported to reduce the chances of embryo implantation, and increase the rate of spontaneous miscarriages, especially if the implantation is close to it or in the niche.

The presence of a niche may increase the difficulty of embryo transfer procedure, clinicians need to be aware of its presence and the transfer should be done under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity.

Still the impact of c.s niche and its characteristics on outcome of ART is not clear.

Eligibility criteria: Inclusion criteria:

1. Aged from 18 - 37 years old.
2. Having a history of one or more previous CS with ultrasonographic visible cesarean section niche (for the group with cs scar niche), which is regarding to European Niche Taskforce is an indentation of the uterine myometrium of at least 2 mm at the site of the CS scar (Jordans et al., 2019).
3. A normal uterus with no anomalies or pathologies.
4. At least one good-quality embryo available for transfer.

Exclusion criteria:

1. Younger than 18 or older than 37 years old.
2. Congenital uterine abnormality or pathology.
3. Presence of a hydrosalpinx.
4. ICSI cycles with TESE samples.

Primary outcomes:
measure: The effect of cesarean scar niche and its characteristics on ongoing pregnancy rate of ART cycles.
timeFrame: 3 months
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Rahem Fertility Center
Study officials:
affiliation: Rahem Fertility Center
name: Eman Elgindy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schepker N, Garcia-Rocha GJ, von Versen-Hoynck F, Hillemanns P, Schippert C. Clinical diagnosis and therapy of uterine scar defects after caesarean section in non-pregnant women. Arch Gynecol Obstet. 2015 Jun;291(6):1417-23. doi: 10.1007/s00404-014-3582-0. Epub 2014 Dec 17.
citation: Clark EA, Silver RM. Long-term maternal morbidity associated with repeat cesarean delivery. Am J Obstet Gynecol. 2011 Dec;205(6 Suppl):S2-10. doi: 10.1016/j.ajog.2011.09.028. Epub 2011 Oct 6.
citation: D'Antonio F, Timor-Tritsch IE, Palacios-Jaraquemada J, Monteagudo A, Buca D, Forlani F, Minneci G, Foti F, Manzoli L, Liberati M, Acharya G, Cali G. First-trimester detection of abnormally invasive placenta in high-risk women: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Feb;51(2):176-183. doi: 10.1002/uog.18840.
citation: Gurol-Urganci I, Bou-Antoun S, Lim CP, Cromwell DA, Mahmood TA, Templeton A, van der Meulen JH. Impact of Caesarean section on subsequent fertility: a systematic review and meta-analysis. Hum Reprod. 2013 Jul;28(7):1943-52. doi: 10.1093/humrep/det130. Epub 2013 May 3.
citation: Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
citation: Sandall J, Tribe RM, Avery L, Mola G, Visser GH, Homer CS, Gibbons D, Kelly NM, Kennedy HP, Kidanto H, Taylor P, Temmerman M. Short-term and long-term effects of caesarean section on the health of women and children. Lancet. 2018 Oct 13;392(10155):1349-1357. doi: 10.1016/S0140-6736(18)31930-5.
citation: Ludwin A, Martins WP, Ludwin I. Evaluation of uterine niche by three-dimensional sonohysterography and volumetric quantification: techniques and scoring classification system. Ultrasound Obstet Gynecol. 2019 Jan;53(1):139-143. doi: 10.1002/uog.19181. No abstract available.
citation: Naji O, Wynants L, Smith A, Abdallah Y, Saso S, Stalder C, Van Huffel S, Ghaem-Maghami S, Van Calster B, Timmerman D, Bourne T. Does the presence of a Caesarean section scar affect implantation site and early pregnancy outcome in women attending an early pregnancy assessment unit? Hum Reprod. 2013 Jun;28(6):1489-96. doi: 10.1093/humrep/det110. Epub 2013 Apr 12.
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