NCT05798624

Brief Summary

As embryo ploidy is a crucial factor not only for implantation but also for maintenance of a pregnancy, the aim of this study is to evaluate the impact of the CS / isthmocele on the ongoing pregnancy rates and the implantation site in single euploid frozen embryo transfer, independent of the endometrial preparation approach.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

March 23, 2023

Last Update Submit

July 16, 2024

Conditions

InfertilityImplantation

Keywords

ImplantationInfertilityIsthmoceleCesarean section

Outcome Measures

Primary Outcomes (4)

  • Ongoing pregnancy rate

    5 weeks

  • Implantation rate

    Number of gestational sacs observed by ultrasound at 6 weeks of gestation divided by the number of embryos transferred

    6 weeks

  • Implantation site

    6 weeks

  • Rate of vaginal bleeding in early pregnancy (until 12 weeks of gestation)

    12 weeks

Study Arms (5)

One CS with isthmocele

Diagnostic Test: Ultrasound between 6+0 and 6+7 weeks of pregnancy - With Isthmocele

More than one CS with Isthmocele

Diagnostic Test: Ultrasound between 6+0 and 6+7 weeks of pregnancy - With Isthmocele

One or more CS without isthmocele

Diagnostic Test: Ultrasound between 6+0 and 6+7 weeks of pregnancy - Without Isthmocele

With previous vaginal delivery

Diagnostic Test: Ultrasound between 6+0 and 6+7 weeks of pregnancy

With first ongoing pregnancy

Diagnostic Test: Ultrasound between 6+0 and 6+7 weeks of pregnancy

Interventions

Ultrasound between 6+0 and 6+7 weeks of pregnancy - With IsthmoceleDIAGNOSTIC_TEST

Location of implantation of the GS (gestational sac) amended to Naji et al, defined as 3 possible implantation sites: (A: fundal, B: anterior, C: posterior) Size of isthmocele: * Depth of isthmocele * Width of isthmocele * Circumference of isthmocele Distance between isthmocele and outer cervical os (measured with the trace line) Distance between CS scar and outer cervical os (measured with the trace line) Size of gestational sac Measurements of the isthmocele size / circumference / distance between isthmocele / CS and outer cervical os

More than one CS with IsthmoceleOne CS with isthmocele
Ultrasound between 6+0 and 6+7 weeks of pregnancy - Without IsthmoceleDIAGNOSTIC_TEST

Location of implantation of the GS amended to Naji et al, defined as 3 possible implantation sites: (A: fundal, B: anterior, C: posterior) Distance between CS scar and outer cervical os (measured with the trace line) Size of gestational sac

One or more CS without isthmocele
Ultrasound between 6+0 and 6+7 weeks of pregnancyDIAGNOSTIC_TEST

Location of implantation of the GS (gestational sac) amended to Naji et al, defined as 3 possible implantation sites (A: fundal, B: anterior, C: posterior) Size of gestational sac

With first ongoing pregnancyWith previous vaginal delivery

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female undergoing IVF/ICSI treatment

You may qualify if:

  • \- All participants undergoing a single euploid FET, independent of the endometrial preparation approach

You may not qualify if:

  • Intracavitary fluid during preparation for FET
  • Known anomaly of the uterus or the adnexae (e.g.: fibroids, polyps, hydrosalpinx, endometriosis, adenomyosis)
  • Embryo which was biopsied on day 7
  • Poor quality embryo which was transferred (Gardner criteria: AC / BC / CB, biopsied on day 6 and CC embryos from both, day 5 and day 6 biopsies, classified as "poor" quality embryos)
  • History of recurrent abortion
  • Antiphospholipid syndrome / autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ART Fertility Clinics LLC

Abu Dhabi, 60202, United Arab Emirates

RECRUITING

Related Publications (14)

  • Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671.

    PMID: 34130991BACKGROUND

  • Bij de Vaate AJ, Brolmann HA, van der Voet LF, van der Slikke JW, Veersema S, Huirne JA. Ultrasound evaluation of the Cesarean scar: relation between a niche and postmenstrual spotting. Ultrasound Obstet Gynecol. 2011 Jan;37(1):93-9. doi: 10.1002/uog.8864.

    PMID: 21031351BACKGROUND

  • Diao J, Gao G, Zhang Y, Wang X, Zhang Y, Han Y, Du A, Luo H. Caesarean section defects may affect pregnancy outcomes after in vitro fertilization-embryo transfer: a retrospective study. BMC Pregnancy Childbirth. 2021 Jul 6;21(1):487. doi: 10.1186/s12884-021-03955-7.

    PMID: 34229640BACKGROUND

  • Evers EC, McDermott KC, Blomquist JL, Handa VL. Mode of delivery and subsequent fertility. Hum Reprod. 2014 Nov;29(11):2569-74. doi: 10.1093/humrep/deu197. Epub 2014 Aug 27.

    PMID: 25164023BACKGROUND

  • Friedenthal J, Alkon-Meadows T, Hernandez-Nieto C, Gounko D, Lee JA, Copperman A, Buyuk E. The association between prior cesarean delivery and subsequent in vitro fertilization outcomes in women undergoing autologous, frozen-thawed single euploid embryo transfer. Am J Obstet Gynecol. 2021 Sep;225(3):287.e1-287.e8. doi: 10.1016/j.ajog.2021.03.026. Epub 2021 Mar 30.

    PMID: 33798478BACKGROUND

  • 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: 23644593BACKGROUND

  • Gurol-Urganci I, Cromwell DA, Mahmood TA, van der Meulen JH, Templeton A. A population-based cohort study of the effect of Caesarean section on subsequent fertility. Hum Reprod. 2014 Jun;29(6):1320-6. doi: 10.1093/humrep/deu057. Epub 2014 Apr 29.

    PMID: 24781430BACKGROUND

  • 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: 31885047BACKGROUND

  • 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: 23585560BACKGROUND

  • Patounakis G, Ozcan MC, Chason RJ, Norian JM, Payson M, DeCherney AH, Yauger BJ. Impact of a prior cesarean delivery on embryo transfer: a prospective study. Fertil Steril. 2016 Aug;106(2):311-6. doi: 10.1016/j.fertnstert.2016.03.045. Epub 2016 Apr 14.

    PMID: 27087400BACKGROUND

  • 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: 30322585BACKGROUND

  • van den Tweel MM, Klijn NF, Diaz de Pool JDN, van der Westerlaken LAJ, Louwe LA. Previous caesarean section is associated with lower subsequent in vitro fertilization live birth rates. Hum Fertil (Camb). 2022 Feb;25(1):93-98. doi: 10.1080/14647273.2019.1696990. Epub 2019 Dec 3.

    PMID: 31793367BACKGROUND

  • Vissers J, Sluckin TC, van Driel-Delprat CCR, Schats R, Groot CJM, Lambalk CB, Twisk JWR, Huirne JAF. Reduced pregnancy and live birth rates after in vitro fertilization in women with previous Caesarean section: a retrospective cohort study. Hum Reprod. 2020 Mar 27;35(3):595-604. doi: 10.1093/humrep/dez295.

    PMID: 32142117BACKGROUND

  • Wang L, Yao W, Tang X, Yao H, Wei S, Huang J, Mol BWJ, Jin L, Yue J, Wang R. Fertility outcomes of IVF/ICSI after Caesarean section: a cohort study. Reprod Biomed Online. 2020 May;40(5):719-728. doi: 10.1016/j.rbmo.2019.12.004. Epub 2019 Dec 16.

    PMID: 32336649BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Barbara Lawrenz, PhD

    ART Fertility Clinics LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Lawrenz, PhD

CONTACT

+971 2 652 8000barbara.lawrenz@artfertilityclinics.com

Jonalyn Edades

CONTACT

+971 2 652 8000jonalyn.edades@artfertilityclinics.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Director

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 4, 2023

Study Start

May 1, 2023

Primary Completion

May 15, 2025

Study Completion

July 30, 2025

Last Updated

July 17, 2024

Record last verified: 2024-07

Locations

AE(1)