InfertilityNCT04839627
Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates.
An observational study of Infertility, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial summary
Serum progesterone levels prepare the endometrium for implantation and play an important role during embryo transfer (ET). In clinical practice, luteal phase support progesterone supplementation is systematically offered to all women undergoing medically assisted procreation (AMP), independently of ET conditions… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- serum progesterone measurement
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2021to 1 Jun 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: all patients who need an embryo transfer in the center.
Who may be able to join
- Age ≥ 18 years
- planned embryo transfer
- signed informed consent
Who cannot join
- patients falsely included, major inclusion criteria not respected
- lack of social insurance
- refusal to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates
Serum progesterone levels prepare the endometrium for implantation and play an important role during embryo transfer (ET). In clinical practice, luteal phase support progesterone supplementation is systematically offered to all women undergoing medically assisted procreation (AMP), independently of ET conditions (fresh and frozen).
The investigators propose to perform a prospective cross-sectional single-center cohort study to measure progesterone levels on the day of the ET on all AMP cycles and to compare these levels between active pregnancies and ET unsuccessful cycles. They will determine progesterone threshold levels corresponding to successful attempts in all ET strategies (fresh and frozen) as well as clinical and biological risk factors leading to luteal phase deficiency during ET. They could therefore individualize progesterone supplementation according to patient's needs.
- Conditions
- Infertility
- Being tested
- serum progesterone measurement
- Keywords
- serum progesterone, embryo transfer, pregnancy rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum progesterone measurementOther
progesterone levels measurement on the day of the embryo transfer on all AMP cycles
| Study group | Role | What they receive |
|---|---|---|
| serum progesterone measurement | Not described Receives: Other: serum progesterone measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum progesterone levels on the day of embryo transfer
µg/L
Measured: During the procedure
Secondary outcomes (1)
pregnancy rate
Post-embryo transfer βHCG levels (UI/l).
Measured: 1 month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start16 Jun 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
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 (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839627
- Sponsor's protocol ID
- PROGESTE
- Status last verified
- Jul 2023
- First submitted
- 30 Mar 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates
- ClinicalTrials.gov ID
- NCT04839627
- Acronym / sponsor ID
- PROGESTE
- Conditions
- Infertility
- Keywords
- serum progesterone, embryo transfer, pregnancy rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 9 Apr 2021 (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.
Serum progesterone levels prepare the endometrium for implantation and play an important role during embryo transfer (ET). In clinical practice, luteal phase support progesterone supplementation is systematically offered to all women undergoing medically assisted procreation (AMP), independently of ET conditions (fresh and frozen).
The investigators propose to perform a prospective cross-sectional single-center cohort study to measure progesterone levels on the day of the ET on all AMP cycles and to compare these levels between active pregnancies and ET unsuccessful cycles. They will determine progesterone threshold levels corresponding to successful attempts in all ET strategies (fresh and frozen) as well as clinical and biological risk factors leading to luteal phase deficiency during ET. They could therefore individualize progesterone supplementation according to patient's needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| serum progesterone measurement | – | Other: serum progesterone measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients who need an embryo transfer in the center.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- planned embryo transfer
- signed informed consent
Key exclusion criteria (3 listed)
- patients falsely included, major inclusion criteria not respected
- lack of social insurance
- refusal to participate in the research
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 |
|---|---|---|
| serum progesterone measurementprogesterone levels measurement on the day of the embryo transfer on all AMP cycles | Other | serum progesterone measurement |
Primary outcome
Serum progesterone levels on the day of embryo transfer
Time frame: During the procedure
µg/L
1 secondary outcome
pregnancy rate
Time frame: 1 month after procedure
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 1 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hospital St. Joseph, Marseille, France at 1 site in France.
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 3 inclusion and 3 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 1 Aug 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 France. 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?
Serum progesterone levels on the day of embryo transfer (time frame: During the procedure). 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 1 Aug 2023.