SubfertilityPFRETNCT05876234
The Predictive Value of Progesterone
An observational study of Subfertility, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
To evaluate a 5 ng/ml serum progesterone (P4) threshold policy for the addition of subcutaneous (SC) P4 in artificially prepared frozen embryo transfer cycles treated with vaginal P4. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women only
- Conditions the study is for
- Subfertility
- How many people
- 3,000 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Apr 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 47 years
- Women only
- No healthy volunteers
- Adult
Study population: Treated at Ghent University Hospital
- Embryo transfer between March 1st 2021 and March 31st 2023
- Determination of progesterone on the day of embryo transfer
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ghent University Hospital - Department of Reproductive Medicine
Ghent, 9000
About this study
Official title: The Predictive Value of the Progesterone Level on the Day of Embryo Transfer in Cryo Cycles
To evaluate a 5 ng/ml serum progesterone (P4) threshold policy for the addition of subcutaneous (SC) P4 in artificially prepared frozen embryo transfer cycles treated with vaginal P4. We assess whether the addition of SC P4 rescues cycles with serum P4 <5 ng/ml and we study the impact of not supplementing cycles with serum P4 >5 ng/ml by comparing them with serum P4 cycles above the conventionally proposed cut-off of 10 ng/ml.
- Conditions
- Subfertility
- Keywords
- progesterone, embryo transfer
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Fetal heart beat at ultrasound
Measured: 11 to 13 weeks after last menstruation
Secondary outcomes (1)
Clinical pregnancy rate
Ultrasound visualisation of the gestational sac
Measured: 6 to 8 weeks after last menstruation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start25 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies 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
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominic Stoop, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876234
- Sponsor's protocol ID
- ONZ-2023-0223
- Acronym
- PFRET
- Status last verified
- Jun 2024
- First submitted
- 8 May 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of the Progesterone Level on the Day of Embryo Transfer in Cryo Cycles
- ClinicalTrials.gov ID
- NCT05876234
- Acronym / sponsor ID
- PFRET / ONZ-2023-0223
- Conditions
- Subfertility
- Keywords
- progesterone, embryo transfer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 May 2023 (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.
To evaluate a 5 ng/ml serum progesterone (P4) threshold policy for the addition of subcutaneous (SC) P4 in artificially prepared frozen embryo transfer cycles treated with vaginal P4. We assess whether the addition of SC P4 rescues cycles with serum P4 <5 ng/ml and we study the impact of not supplementing cycles with serum P4 >5 ng/ml by comparing them with serum P4 cycles above the conventionally proposed cut-off of 10 ng/ml.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Treated at Ghent University Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ongoing pregnancy rate
Time frame: 11 to 13 weeks after last menstruation
Fetal heart beat at ultrasound
1 secondary outcome
Clinical pregnancy rate
Time frame: 6 to 8 weeks after last menstruation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Dominic Stoop, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subfertility, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 11 to 13 weeks after last menstruation). 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 5 Jun 2024.