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NCT Number: NCT05798624

Impact of a Previous CS on the Ongoing Pregnancy Rate in Single Euploid Frozen Embryo Transfer (ET)

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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

The impact of a previous CS on the future fertility in the general population is discussed controversially, but it seems that the clinical and social circumstances leading to the CS have a greater effect on future fertility than the surgical procedure itself (Gurol-Urganci et al., 2013, 2014; Evers et al., 2014). However, this might be different in women who do not conceive spontaneously after a previous CS and need to undergo ART due to secondary infertility. Whereas some studies describe a reduction of implantation, ongoing pregnancy, and live birth (LB) rates (Vissers et al., 2020; Wang et al., 2020; Diao et al., 2021; Friedenthal et al., 2021; van den Tweel et al., 2022), others describe a negative impact of a previous CS only in the presence of an isthmocele (Diao et al., 2021) or no impact (Patounakis et al., 2016).

A case control study evaluated whether there are any differences in the location and distance to the internal cervical ostium of the implantation site of the intrauterine gestation sacs, early pregnancy symptoms and pregnancy outcome at 12 weeks gestation between women with and without a previous Caesarean section (CS) in patients who conceived naturally (Naji et al., 2013). Investigators concluded that the presence of a CS scar affects the site of implantation, and also that the distance between implantation site and the scar is related to the risk of spontaneous abortion.

This is a purely observational study without any intervention. Participants will be stratified into different groups according to their previous obstetrical history. Total sample size will include 1050 participants undergoing a frozen embryo transfer (FET) cycle.

Isthmocele will be defined according to de Vaate et al (Bij de Vaate et al., 2011) as: visible anechogenic area of at least 1 mm depth at the site of the Cesarean scar.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Diagnostic 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

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

Diagnostic 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

Ultrasound between 6+0 and 6+7 weeks of pregnancy

Diagnostic 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

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: 5 weeks

  2. Implantation rate

    Time frame: 6 weeks

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

  3. Implantation site

    Time frame: 6 weeks

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

    Time frame: 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Lawrenz, PhD

CONTACT

[email protected]

+971 2 652 8000 ext. 1108

Jonalyn Edades

CONTACT

[email protected]

+971 2 652 8000 ext. 1106

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Official study title

To Study the Impact of a Previous Cesarean Section (CS) With / Without an Isthmocele on the Ongoing Pregnancy Rate in Single Euploid Frozen Embryo Transfer

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2023
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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