Cesarean Section Scar Niche: The Impact on ART Outcome

NCT05358678 | Unknown

• 1 other identifier: 9385
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cesarean Section; ART

Keywords

Cesarean Section niche; ART

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical pregnancy

  6 weeks

Study Arms (2)

cases with cs niche

133 cases with cs niche undergoing ART will be included. Pituitary suppression will be achieved by long or antagonist protocol. For long protocol, GnRH agonist will be administered for 10-14 days starting from mid-luteal phase of preceding cycle. After confirmation of down regulation, gonadotropins will be given from second or third day of cycle in a daily dose of (150-300 IU). Gonadotropins therapy will be tailored according to age, BMI, antral follicle count, antimullerian hormone and previous response. In antagonist protocol, gonadotropins will be given from second or third day of cycle in a daily dose of (150-300 IU). GnRH antagonist will be adjusted according to patient response. On the 5th -6th day of stimulation, sonography will be performed and repeated every 1-3 days with regular estradiol assessment. When at least 3 follicles reach ≥ 17 mm in mean diameter, trigger will be given. Oocytes pick up will be performed 34-36 hour after triggering.

Diagnostic Test: cs niche group

cases without cs niche

133 cases without cs niche undergoing ART will be included. Pituitary suppression will be achieved by long or antagonist protocol. For long protocol, GnRH agonist will be administered for 10-14 days starting from mid-luteal phase of preceding cycle. After confirmation of down regulation, gonadotropins will be given from second or third day of cycle in a daily dose of (150-300 IU). Gonadotropins therapy will be tailored according to age, BMI, antral follicle count, antimullerian hormone and previous response. In antagonist protocol, gonadotropins will be given from second or third day of cycle in a daily dose of (150-300 IU). GnRH antagonist will be adjusted according to patient response. On the 5th -6th day of stimulation, sonography will be performed and repeated every 1-3 days with regular estradiol assessment. When at least 3 follicles reach ≥ 17 mm in mean diameter, trigger will be given. Oocytes pick up will be performed 34-36 hour after triggering.

Interventions

cs niche group DIAGNOSTIC_TEST

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: 1. Simple niche 2. Simple niche with one branch 3. 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.

cases with cs niche

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Aged from 18 - 37 years old.
• 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).
• A normal uterus with no anomalies or pathologies.
• At least one good-quality embryo available for transfer.

You may not qualify if:

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

Sponsors & Collaborators

• Rahem Fertility Center: lead
• Zagazig University: collaborator

Study Sites (1)

Rahem Fertility Center

Zagazig, 44511, Egypt

RECRUITING

Related Publications (9)

• 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.

  PMID: 25516174 BACKGROUND

• 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.

  PMID: 22114995 BACKGROUND

• 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.

  PMID: 28833750 BACKGROUND

• 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.

  PMID: 23644593 BACKGROUND

• 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.

  PMID: 29536581 BACKGROUND

• 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.

  PMID: 30322585 BACKGROUND

• 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.

  PMID: 30039641 BACKGROUND

• 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.

  PMID: 23585560 BACKGROUND

• 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.

  PMID: 31885047 BACKGROUND

Study Officials

• Eman Elgindy, MD, PhD

  Rahem Fertility Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana nabil, MSc

CONTACT

01005899460; rananabil51@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of obstetrics and Gynecology Zagazig University Faculty of Medicine

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: May 3, 2022
• Study Start: May 25, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

EG (1)