An interventional study of Progesterone in IVF, sponsored by Hillel Yaffe Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Other
To determine if different serum Progesterone levels on FET day are associated with different clinical pregnancy rates (CPR), and if increasing dosage of vaginal Progesterone in cases of lower serum Progesterone level on FET day can be either beneficial or detrimental regarding the CPR.
Over the past decade, the use of frozen-thawed embryo transfer (FET) has risen around the globe. There is no consensus which mode of FET is superior, either natural cycle (NC) or artificial cycle (AC) with hormonal replacement therapy (HRT). The latter has become more and more popular because it allows more flexibility in timing of FET and it requires fewer visits for monitoring before the transfer. AC also has the advantage of a more precise control of progesterone (P) exposure, which is of utmost importance for controlling the window of implantation between the embryo and the endometrium. Although FET in AC give excellent results, there is still a need for improvement, as the ideal dose is not individualized to a patient's characteristics and serum P required for optimal cycle outcome haven't been established.
Retrospective studies about P levels on the day of FET in AC cycles showed contradictory results regarding cycle outcomes. Several studies showed that a lower P levels on FET day, or one day prior, are associated with lower clinical pregnancy rate (CPR) or live birth rate (LBR), whereas one study showed that women with higher P on FET day were having lower LBRs. Recently, a prospective study showed that serum P level \< 9.2 ng/ml on the day of FET in oocyte reception cycles was associated with a significant lower ongoing pregnancy rate. Considering these previous studies, we wanted to determine if different serum P levels on FET day are associated with different CPR, and if increasing dosage of vaginal P in cases of lower serum P level on FET day can be either beneficial or detrimental.
Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
P \< 10.0 ng/ml with increasing P dosage from 800 mg to 1200 mg daily from the FET day.
Drug: Progesterone
P \< 10.0 ng/ml without change in drug regimen.
Drug: Progesterone
P ≥ 10.0 ng/ml without change in drug regimen.
Drug: Progesterone
To determine if different serum P levels on FET day are associated with different clinical pregnancy rates (CPR)
Clinical pregnancy rate
Clinical pregnancy rate according to the presence of pregnancy sac on week 6-7 US.
Time frame: 1 Year per patient
Laboratory end other long term outcomes
chemical pregnancy rate, miscarriage rate, and live birth rates.
Time frame: 1 Year per patient
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Hillel Yaffe Medical Center