To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.
In case the study will show that the live birth rate in single euploid NC frozen embryo transfer cycles without LPS is not inferior to NC cycles with LPS, treatment can be simplified, and participants comfort can be increased.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
342
Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng/ml (Irani et al., 2017).
On day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy
ART Fertility Clinics LLC
Abu Dhabi, United Arab Emirates
RECRUITINGART Fertility Clinics Al Ain
Al Ain City, United Arab Emirates
RECRUITINGART Fertility Clinics Dubai
Dubai, United Arab Emirates
NOT_YET_RECRUITINGImplantation rate
Number of embryos which have produced ultrasonographic evidence of an intrauterine gestational sac per the total number of embryos transferred into the uterine cavity (Zegers-Hochschild et al., 2009).
Time frame: 2 months
Clinical pregnancy rate
hCG \> 15 Iu/ml and ultrasound confirmation of a gestational sac
Time frame: 2 months
Live birth rate
Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009)
Time frame: 41 weeks
Serum P4 levels on ET day
Progesterone level on the day of embryo transfer
Time frame: 1 day
Serum E2 and P4 levels on day 5 or 6 after ET procedure
Estradiol and Progesterone levels on day 5 or 6 after embryo transfer
Time frame: 6 days
Serum E2 and P4 levels on day 10 after ET procedure
Estradiol and Progesterone levels on day 10 after embryo transfer
Time frame: 10 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure
Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.
The procedure in which embryo is placed in the uterus.
Pregnancy will be confirmed / excluded by measurement of serum hCG 10 days after ET procedure and a level of \> 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006)
Serum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure