IVFPLATONCT07252622
Progesterone Levels and Frozen Embryo Transfer Outcomes
An observational study of IVF, run by Shady Grove Fertility Reproductive Science Center.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- Blood draw
- How many people
- 659 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Nov 2028
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Study population: All patients undergoing programmed frozen embryo transfer of a single euploid embryo with combined vaginal progesterone and intramuscular PIO.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
- 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.
- 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.
- Conditions
- IVF
- Being tested
- Blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
All patients will have one additional blood draw on the day of their transfer to measure progesterone level.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 659 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Shady Grove Fertility Reproductive Science Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252622
- Sponsor's protocol ID
- Pro00089821
- Acronym
- PLATO
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Levels and Frozen Embryo Transfer Outcomes
- ClinicalTrials.gov ID
- NCT07252622
- Acronym / sponsor ID
- PLATO / Pro00089821
- Conditions
- IVF
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 659 participants (estimated)
- Lead sponsor
- Shady Grove Fertility Reproductive Science CenterUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All patients undergoing programmed frozen embryo transfer of a single euploid embryo with combined vaginal progesterone and intramuscular PIO.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawAll patients will have one additional blood draw on the day of their transfer to measure progesterone level. | Other | – |
Primary outcome
Ongoing pregnancy
Time frame: Through study completion, an average of 1 year
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of IVF, run by Shady Grove Fertility Reproductive Science Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Boedeker (301-545-1423, platostudy@sgfertility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.