Progesterone Levels and Frozen Embryo Transfer Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood draw.
- Who it may be relevant to
- Registry conditions: IVF. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Blood draw
All patients will have one additional blood draw on the day of their transfer to measure progesterone level.
Primary outcome measures
- Ongoing pregnancy [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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.
- 18 years and older
Exclusion criteria
- 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.
- Planned use of embryos cryopreserved by slow-freeze, prior to blastocyst stage, or other than PGT-A normal.
- Currently breast feeding, pregnancy, or having a contraindication to pregnancy.
- Participation in any experimental drug study within 60 days prior to screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07252622 · Pro00089821