Cesarean Section Scar Niche: The Impact on ART Outcome

Cesarean Section Clinical Trial

Official title:

Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358678
• Other study ID #: 9385
• Status: Recruiting
• Start date: May 25, 2022
• Est. completion date: May 2023

Study information

• Verified date: October 2022
• Source: Rahem Fertility Center
• Contact: Rana nabil, MSc
• Phone: 01005899460
• Email: rananabil51[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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.

Related Conditions & MeSH terms

• ART
• Cesarean Section

Intervention

Diagnostic Test:
• cs niche group
A niche is formally defined by the European Niche Taskforce as an indentation of the uterine myometrium of at least 2 mm at the site of the CS scars. A niche can be sub classified as follows: Simple niche Simple niche with one branch Complex niche (with more than one branch). The following measurements will be taken: Length. Depth. Width. RMT (residual myometrium thickness). AMT (adjacent myometrium thickness). Distance between the niche and the VV (vesico-vaginal) fold. Distance between the niche and the external os. We will also comment on the position of the uterus (AVF or RVF), presence or absence of intra cavitary fluid and its thickness.

Locations

Country	Name	City	State
Egypt	Rahem Fertility Center	Zagazig

Sponsors (2)

Lead Sponsor	Collaborator
Rahem Fertility Center	Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

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. — View 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, Calì 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. Review. — View 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. Review. — View Citation

Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brölmann 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. — View Citation

Lawrenz B, Melado L, Garrido N, Coughlan C, Markova D, Fatemi H. Isthmocele and ovarian stimulation for IVF: considerations for a reproductive medicine specialist. Hum Reprod. 2020 Jan 1;35(1):89-99. doi: 10.1093/humrep/dez241. — View 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. — View 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. — View 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. Review. — View Citation

Schepker N, Garcia-Rocha GJ, von Versen-Höynck 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of cesarean scar niche and its characteristics on ongoing pregnancy rate of ART cycles.	Ongoing pregnancy: defined as a viable intrauterine pregnancy of at least 12 weeks duration confirmed on an ultrasound scan	3 months
Secondary	Clinical pregnancy	Clinical pregnancy: A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs.	6 weeks