Health TrialsbyHealthPanel

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

ConditionsInfertilityImplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-42
SponsorART Fertility Clinics LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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)

Trial population

Female undergoing IVF/ICSI treatment

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

1,050 Participants
are divided into 5 treatment groups
Group A: One CS with isthmocele1 intervention
Group B: More than one CS with Isthmocele1 intervention
Group C: One or more CS without isthmocele1 intervention
Group D: With previous vaginal delivery1 intervention
Group E: With first ongoing pregnancy1 intervention

Trial outcomes

Primary outcomes

1

Ongoing pregnancy rate

Time frame
5 weeks
2

Implantation rate

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

Time frame
6 weeks
3

Implantation site

Time frame
6 weeks
4

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

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ART Fertility Clinics LLC

Lead sponsor

Source ClinicalTrials.gov
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