InfertilityNCT05323513
The Correlation Between Luteal Serum Progesterone and Live Birth Rate
An observational study of Infertility, run by Peter Humaidan at 1 site in Denmark.
Trial summary
The study design is an observational cohort study. Level of serum P4 will be collected on day OR+4 as well as on the day of embryo transfer (ET) either day OR+3 or OR+5. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Infertility
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Mar 2022to 1 May 2024
- 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 41 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients treated at The Fertility Clinic, Regional Hospital in Skive, who meets the inclusion criteria will be invited to participate in the study.
Who may be able to join
- Signed informed consent
- BMI <35kg/m2
Who cannot join
- No fresh embryo transfer
- Prior participation in the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Fertilitetsklinikken, Regionshospitalet Skive
Skive, 7800
Peter Humaidan, Professor, +4578445760, peter.humaidan@midt.rm.dk
Peter Humaidan, M.D.
About this study
Official title: The Correlation Between Luteal Serum Progesterone and Live Birth Rate in IVF - a Prospective Cohort Study (LUT-2)
The study design is an observational cohort study. Level of serum P4 will be collected on day OR+4 as well as on the day of embryo transfer (ET) either day OR+3 or OR+5.
- Conditions
- Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate in relation to luteal serum progesterone levels on day four and three or five
The birth of a live born child after gestational week 22+0
Measured: 9-24 months after inclusion
Secondary outcomes (2)
Pregnancy rate in relation to luteal serum progesterone levels
Serum Human chorionic gonadotropin<10 IU/l
Measured: 14-16 days after oocyte retrieval
Clinical pregnancy rate in relation to luteal serum progesterone levels
Ultrasound scan detection of intrauterine fetal heartbeat in gestational week 7-9
Measured: 7-9 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start10 Mar 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
- Investigators
- Peter Humaidan, Professor, Principal investigator, Fertilitetsklinikken, Regionshospitalet Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323513
- Sponsor's protocol ID
- LUT-2
- Status last verified
- Jul 2023
- First submitted
- 4 Apr 2022
- Last updated
- 6 Jul 2023
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Luteal Serum Progesterone and Live Birth Rate in IVF - a Prospective Cohort Study (LUT-2)
- ClinicalTrials.gov ID
- NCT05323513
- Acronym / sponsor ID
- LUT-2
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 12 Apr 2022 (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.
The study design is an observational cohort study. Level of serum P4 will be collected on day OR+4 as well as on the day of embryo transfer (ET) either day OR+3 or OR+5.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients treated at The Fertility Clinic, Regional Hospital in Skive, who meets the inclusion criteria will be invited to participate in the study.
Key inclusion criteria (2 listed)
- Signed informed consent
- BMI <35kg/m2
Key exclusion criteria (2 listed)
- No fresh embryo transfer
- Prior participation in the study
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
Live birth rate in relation to luteal serum progesterone levels on day four and three or five
Time frame: 9-24 months after inclusion
The birth of a live born child after gestational week 22+0
2 secondary outcomes
Pregnancy rate in relation to luteal serum progesterone levels
Time frame: 14-16 days after oocyte retrieval
Clinical pregnancy rate in relation to luteal serum progesterone levels
Time frame: 7-9 weeks after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- 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.
Peter Humaidan, Professor principal investigator
Fertilitetsklinikken, Regionshospitalet Skive
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, run by Peter Humaidan at 1 site in Denmark.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. 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 Denmark. 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?
Contact Peter Humaidan, Professor (78445760 ext. +45, peter.humaidan@midt.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate in relation to luteal serum progesterone levels on day four and three or five (time frame: 9-24 months after inclusion). 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 6 Jul 2023.