InfertilityOTECNCT04290520
Optimization of Frozen Embryo Transfers by Studying Progesterone on the Day of Transfer
An observational study of Infertility and IVF, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The number of embryo transfers after freezing has increased over the last 10 years due to improvements in embryo freezing techniques and in particular the development of vitrification. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility, IVF
- What is being tested?
- bioassay
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 31 Dec 2020
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Study population: These are MPA patients who have undergone embryo freezing and endometrial preparation for embryo replacement.
Who may be able to join
- Patients who have benefited from a frozen embryo transfer during the inclusion period in the MPA centre of the CHU Caremeau Nimes are included.
- Adult patient (≥18 years of age) and under 43 years of age.
Who cannot join
- Patients who did not receive progesterone dosing on the day of transfer are excluded from the study.
- Patients who objected to the use of their data.
Trial locations and contacts
1 site in 1 country.
About this study
The number of embryo transfers after freezing has increased over the last 10 years due to improvements in embryo freezing techniques and in particular the development of vitrification. This has also been made possible by changes in clinical protocols favouring freezing in patients at high risk of hyperstimulation and by different methods of endometrial preparation to receive embryos after rewarming.
In fact, embryo transfer requires endometrial preparation to make implantation possible. There are various protocols for endometrial preparation. Endometrial preparations in the natural cycle, with or without induction of ovulation by FSH, require more regular monitoring, and allow the development of a main follicle that will give a corpus luteum that will secrete progesterone in the luteal phase, which can be supported by the supply of exogenous progesterone. In contrast, endometrial preparations in hormone replacement therapy (HRT) cycles are done by administering estradiol orally or transdermally to stimulate endometrial growth while blocking the patient's gonadotropic axis, and administering progesterone in the luteal phase to differentiate the endometrium. This preparation has the advantage of being simpler to monitor and organize.
Read more
There is currently no consensus on a type of preparation that would give better results, and although the literature seems to show that there would be more miscarriages in a substituted cycle, there does not seem to be any difference in the birth rate per cycle in the end, whatever the type of endometrial preparation.
Some teams have shown that in HRT, there appears to be more miscarriage when the progesterone level measured on the day of the frozen embryo transfer is lower, especially below a threshold of 9ng/mL. Labarta showed ESHRE in July 2019 that modifying the endometrial preparation if the progesterone level is below 9ng/mL on the day of transfer by adding subcutaneous progesterone (Progiron) resulted in a lower miscarriage rate, comparable to the usual miscarriage rates in spontaneous pregnancy.
Thus, if the miscarriage rate is higher in HRT than in the natural cycle, and if this is related to "luteal insufficiency" characterized by a lower circulating serum progesterone level, the hypothesis of this study in the investigator's population would be that the serum progesterone level on the day of the frozen embryo transfer would be lower in HRT than in the spontaneous cycle.
- Conditions
- Infertility, IVF
- Being tested
- bioassay
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioassayOther
Serum progesterone level (ng/ml)
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of our study is to compare progesterone levels on the day of embryo transfer according to the endometrial preparation protocol.
Serum progesterone level (ng/ml)
Measured: the day of the embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290520
- Sponsor's protocol ID
- Local/2020/SH-01
- Acronym
- OTEC
- Status last verified
- Jun 2023
- First submitted
- 27 Feb 2020
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Frozen Embryo Transfers by Studying Progesterone on the Day of Transfer
- ClinicalTrials.gov ID
- NCT04290520
- Acronym / sponsor ID
- OTEC / Local/2020/SH-01
- Conditions
- Infertility, IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Mar 2020 (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 number of embryo transfers after freezing has increased over the last 10 years due to improvements in embryo freezing techniques and in particular the development of vitrification. This has also been made possible by changes in clinical protocols favouring freezing in patients at high risk of hyperstimulation and by different methods of endometrial preparation to receive embryos after rewarming.
In fact, embryo transfer requires endometrial preparation to make implantation possible. There are various protocols for endometrial preparation. Endometrial preparations in the natural cycle, with or without induction of ovulation by FSH, require more regular monitoring, and allow the development of a main follicle that will give a corpus luteum that will secrete progesterone in the luteal phase, which can be supported by the supply of exogenous progesterone. In contrast, endometrial preparations in hormone replacement therapy (HRT) cycles are done by administering estradiol orally or transdermally to stimulate endometrial growth while blocking the patient's gonadotropic axis, and administering progesterone in the luteal phase to differentiate the endometrium. This preparation has the advantage of being simpler to monitor and organize.
There is currently no consensus on a type of preparation that would give better results, and although the literature seems to show that there would be more miscarriages in a substituted cycle, there does not seem to be any difference in the birth rate per cycle in the end, whatever the type of endometrial preparation.
Some teams have shown that in HRT, there appears to be more miscarriage when the progesterone level measured on the day of the frozen embryo transfer is lower, especially below a threshold of 9ng/mL. Labarta showed ESHRE in July 2019 that modifying the endometrial preparation if the progesterone level is below 9ng/mL on the day of transfer by adding subcutaneous progesterone (Progiron) resulted in a lower miscarriage rate, comparable to the usual miscarriage rates in spontaneous pregnancy.
Thus, if the miscarriage rate is higher in HRT than in the natural cycle, and if this is related to "luteal insufficiency" characterized by a lower circulating serum progesterone level, the hypothesis of this study in the investigator's population would be that the serum progesterone level on the day of the frozen embryo transfer would be lower in HRT than in the spontaneous cycle.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- These are MPA patients who have undergone embryo freezing and endometrial preparation for embryo replacement.
Key inclusion criteria (2 listed)
- Patients who have benefited from a frozen embryo transfer during the inclusion period in the MPA centre of the CHU Caremeau Nimes are included.
- Adult patient (≥18 years of age) and under 43 years of age.
Key exclusion criteria (2 listed)
- Patients who did not receive progesterone dosing on the day of transfer are excluded from the study.
- Patients who objected to the use of their data.
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 |
|---|---|---|
| bioassaySerum progesterone level (ng/ml) | Other | – |
Primary outcome
The main objective of our study is to compare progesterone levels on the day of embryo transfer according to the endometrial preparation protocol.
Time frame: the day of the embryo transfer
Serum progesterone level (ng/ml)
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 6 Jun 2023.
- 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. 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 and IVF, run by Centre Hospitalier Universitaire de Nīmes 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 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: finished, as of the sponsor's last update on 6 Jun 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?
The main objective of our study is to compare progesterone levels on the day of embryo transfer according to the endometrial preparation protocol. (time frame: the day of the embryo transfer). 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 Jun 2023.