ART Fertility Clinics LLC
Abu Dhabi, 60202, United Arab Emirates
Location status: Recruiting
NCT Number: NCT05798624
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.
Interested in participating?
Request Info18 year–42 year
Female
Observational
Abu Dhabi, 60202, United Arab Emirates
Location status: Recruiting
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
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
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
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
Time frame: 5 weeks
Time frame: 6 weeks
Number of gestational sacs observed by ultrasound at 6 weeks of gestation divided by the number of embryos transferred
Time frame: 6 weeks
Time frame: 12 weeks
Interested in participating?
Request InfoART Fertility Clinics LLC
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT05440617
Acute Ovarian Failure, Early Menopause And Infertility In Females After Treatment For Childhood Cancer
Bethesda, Maryland, United States
View Trial DetailsNCT05693220
Adnexal Diseases, Anovulation
San Francisco, California, United States
View Trial DetailsNCT07814235
Aging, Assisted Reproduction Technologies
Murcia, Spain
View Trial DetailsNCT07508657
Genital Diseases, Infertility
Copenhagen, Denmark
View Trial Details