Progesterone Levels and Frozen Embryo Transfer Outcomes
ConditionIVF
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorShady Grove Fertility Reproductive Science Center
About this trial
Frozen embryo transfers (FET) now represent the majority of all embryo transfer cycles, and upwards of 60% live births in United States are now attributable to frozen embryo transfers (1). Exogenous progesterone for endometrial decidualization and luteal phase support is thought to be critical to both optimizing endometrial receptivity for implantation as well as sustaining early pregnancy prior to reliable secretory activity of the early placenta.
The purpose of this study is to:
1. Determine the prevalence of low serum progesterone levels (less than 10 ng/ml) among patients undergoing a programmed embryo transfer cycle on the day of frozen embryo transfer. 2. Determine if serum progesterone \< 10 ng/ml on the day of frozen embryo transfer is associated with poorer FET outcomes: ongoing pregnancy (primary outcome), live birth, biochemical pregnancy, and clinical pregnancy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Female patient undergoing programmed frozen embryo transfer using exogenous estrogen and progesterone, with exogenous progesterone administered via a combination of vaginal progesterone (Endometrin®) (2-3 times daily) and intermittent progesterone-in-oil (PIO) (every 3rd day) according to standard protocol. Protocols involving other formulations of vaginal progesterone (e.g. Crinone®, Prometrium®, will also be included).
Planned transfer one 1 euploid embryo. Recruited patients will have at least 1 euploid embryo available for transfer.
Standard eligibility criteria to undergo frozen embryo transfer at Shady Grove Fertility.
Disqualifiers
Age less than 18 years or greater than 51 years
Planned intervention based on serum progesterone concentration measured any time after initiation of intramuscular or vaginal progesterone.
Uterine cavity abnormality that has not been surgically corrected.
Any medical or surgical contraindication to undergoing programmed frozen embryo transfer or pregnancy.
Trial population
All patients undergoing programmed frozen embryo transfer of a single euploid embryo with combined vaginal progesterone and intramuscular PIO.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood draw
Other interventionAll patients will have one additional blood draw on the day of their transfer to measure progesterone level.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Ongoing pregnancy
At the completion of the study, a chart review will be performed to determine which patients who participated in this study have an ongoing pregnancy. This information is recorded in our electronic medical record as a binary variable (ongoing pregnancy - yes or no).
Time frame
Through study completion, an average of 1 yearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: