InfertilityProFETNCT04170517
Serum Progesterone Levels on the Day of Frozen Embryo Transfer (FET) and Pregnancy Outcomes
An observational study of Infertility and Infertility, Female, run by CARE Fertility UK at 1 site in United Kingdom.
Trial summary
Frozen embryo transfer (FET) cycles have become more common in recent years due to a push towards elective single embryo transfer (SET). While it is known that progesterone supplementation during the luteal phase improves clinical pregnancy rates, there is a paucity of prospective data on the impact of serum… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Infertility, Female, IVF
- What is being tested?
- Measurement of serum progesterone on the day of FET
- How many people
- 402 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2020to 31 Dec 2021
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All women undergoing ART with FET.
Who may be able to join
- All women undergoing ART with FET.
Who cannot join
- None. We aim to study the "every day" patient undergoing FET, and for this we intend to keep the population of the study as unselected as possible.
Trial locations and contacts
1 site in 1 country.
About this study
Frozen embryo transfer (FET) cycles have become more common in recent years due to a push towards elective single embryo transfer (SET). While it is known that progesterone supplementation during the luteal phase improves clinical pregnancy rates, there is a paucity of prospective data on the impact of serum progesterone levels on pregnancy outcomes in FET cycles. This multicentre prospective cohort study aims to investigate the association between serum progesterone levels on the day of FET and pregnancy outcomes, and to determine a serum progesterone cut-off value above which clinical pregnancy and live birth are more likely to occur. Women undergoing ART-FET cycles at CARE Fertility clinics in the UK will be recruited and their serum progesterone measured on the day of frozen embryo transfer. Follow-up data will be stored in electronic patient records and analysed to determine whether a low serum progesterone level on the day of FET adversely affects ART outcomes.
- Conditions
- Infertility, Infertility, Female, IVF
- Being tested
- Measurement of serum progesterone on the day of FET
- Medical subject headings
- Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of serum progesterone on the day of FETDiagnostic test
Measurement of serum progesterone on the day of FET
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate per participant
Birth of a live fetus at 24 or more weeks of gestational age
Measured: 18 months
Secondary outcomes (5)
Miscarriage rate per participant and per pregnancy
Any clinical pregnancy lost before week 12 of gestation per participant (number of events/number of participants, %)
Measured: 18 months
Implantation rates per participant
Number of gestational sacs seen in a 2D transvaginal ultrasound scan divided by the number of embryos transferred per patient (number of events/number of embryos transferred, %)
Measured: 18 months
Biochemical pregnancy rate per participant
Positive pregnancy test following embryo transfer per participant (number of events/number of participants, %)
Measured: 18 months
Clinical pregnancy rate per participant
Presence of at least one gestational sac on ultrasound (number of events/number of participants, %)
Measured: 18 months
Ectopic pregnancy rate per participant
number of events/number of participants, %
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start2 Jan 2020
- Primary completion28 Feb 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- CARE Fertility UK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arri Coomarasamy, MBChB MD FRCOG, Principal investigator, CARE Fertility UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170517
- Sponsor's protocol ID
- ProFETStudy
- Acronym
- ProFET
- Status last verified
- Aug 2022
- First submitted
- 12 Nov 2019
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers. Any IPD will be confined to the purposes of the study.
Publications
Melo P, Wood S, Petsas G, Chung Y, Easter C, Price MJ, Fishel S, Khairy M, Kingsland C, Lowe P, Rajkhowa M, Sephton V, Pandey S, Kazem R, Walker D, Gorodeckaja J, Wilcox M, Gallos I, Tozer A, Coomarasamy A. The effect of frozen embryo transfer regimen on the association between serum progesterone and live birth: a multicentre prospective cohort study (ProFET). Hum Reprod Open. 2022 Nov 28;2022(4):hoac054. doi: 10.1093/hropen/hoac054. eCollection 2022.
PubMed 36518987
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Progesterone Levels on the Day of Frozen Embryo Transfer (FET) and Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT04170517
- Acronym / sponsor ID
- ProFET / ProFETStudy
- Conditions
- Infertility, Infertility, Female, IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- CARE Fertility UKUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Nov 2019 (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 transfer (FET) cycles have become more common in recent years due to a push towards elective single embryo transfer (SET). While it is known that progesterone supplementation during the luteal phase improves clinical pregnancy rates, there is a paucity of prospective data on the impact of serum progesterone levels on pregnancy outcomes in FET cycles. This multicentre prospective cohort study aims to investigate the association between serum progesterone levels on the day of FET and pregnancy outcomes, and to determine a serum progesterone cut-off value above which clinical pregnancy and live birth are more likely to occur. Women undergoing ART-FET cycles at CARE Fertility clinics in the UK will be recruited and their serum progesterone measured on the day of frozen embryo transfer. Follow-up data will be stored in electronic patient records and analysed to determine whether a low serum progesterone level on the day of FET adversely affects ART outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women undergoing ART with FET.
Key inclusion criteria (1 listed)
- All women undergoing ART with FET.
Key exclusion criteria (1 listed)
- None. We aim to study the "every day" patient undergoing FET, and for this we intend to keep the population of the study as unselected as possible.
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 |
|---|---|---|
| Measurement of serum progesterone on the day of FETMeasurement of serum progesterone on the day of FET | Diagnostic test | – |
Primary outcome
Live birth rate per participant
Time frame: 18 months
Birth of a live fetus at 24 or more weeks of gestational age
5 secondary outcomes
Miscarriage rate per participant and per pregnancy
Time frame: 18 months
Implantation rates per participant
Time frame: 18 months
Biochemical pregnancy rate per participant
Time frame: 18 months
Clinical pregnancy rate per participant
Time frame: 18 months
Ectopic pregnancy rate per participant
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Derived from this study: PubMed 36518987Melo P, Wood S, Petsas G, Chung Y, Easter C, Price MJ, Fishel S, Khairy M, Kingsland C, Lowe P, Rajkhowa M, Sephton V, Pandey S, Kazem R, Walker D, Gorodeckaja J, Wilcox M, Gallos I, Tozer A, Coomarasamy A. The effect of frozen embryo transfer regimen on the association between serum progesterone and live birth: a multicentre prospective cohort study (ProFET). Hum Reprod Open. 2022 Nov 28;2022(4):hoac054. doi: 10.1093/hropen/hoac054. eCollection 2022.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers. Any IPD will be confined to the purposes of the study.
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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.
Arri Coomarasamy, MBChB MD FRCOG principal investigator
CARE Fertility UK
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 Infertility and Infertility, Female, run by CARE Fertility UK at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Aug 2022. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Live birth rate per participant (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04170517, which also lists 1 linked publication.
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 29 Aug 2022.