Infertility, FemaleCORPUS-LUTEUMNCT04259996
Impact of Serum Progesterone in Modified Natural Cycles and Stimulated Cycles on Ongoing Pregnancy Rate
An observational study of Infertility, Female, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
Prospective cohort unicentric study including infertile patients undergoing an embryo transfer in the context of natural or stimulated cycles and receiving luteal phase support with vaginal natural progesterone following the clinical practice in our clinic in IVIRMA Valencia, Spain. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENT
- Type of treatment
- Surgery or procedure
- How many people
- 488 participants
- Where
- 1 siteSpain
- Study dates
- 19 Feb 2020to 1 Jul 2023
- How long will I take part?
- 1 Year
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All infertile patients undergoing a fresh or frozen blastocyst transfer (two blastocysts transferred as maximum) from own or donated oocytes; in the context of a modified natural cycle (group A) or a stimulated cycle (group B). As usually performed in our daily clinical practice, all patients will receive hCG to trigger ovulation and maintain the corpus luteum to produce endogenous progesterone. Luteal phase support will be given as usual according to the routine in our center.
Who may be able to join
- The subject must provide written informed consent prior to any study related procedures
- Women ≤50 years old
- BMI ≤ 40 kg/m2
- Adequate endometrial thickness (>6.5mm) and pattern (Triple A structure) in the proliferative phase
- Regular menstrual cycles
Who cannot join
- Uterine Pathology, adnexal pathology
- Systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Serum Progesterone Concentration on the Day of Embryo Transfer in Modified Natural Cycles and Stimulated Cycles on Ongoing Pregnancy Rate
Prospective cohort unicentric study including infertile patients undergoing an embryo transfer in the context of natural or stimulated cycles and receiving luteal phase support with vaginal natural progesterone following the clinical practice in our clinic in IVIRMA Valencia, Spain.
Read the detailed description
Progesterone as a promoter of endometrial maturation is essential for the process of embryo implantation. The transformation of the endometrium from a proliferative state to a receptive state depends on the adequate progesterone exposure of the endometrium. Therefore, in any assisted reproduction technique (ART) the management of the luteal phase with exogenous administered progesterone, aiming to achieve a receptive endometrial state, is an essential part of the therapy. This important part of infertility-treatment is called luteal phase support (LPS).
Currently, there is a scientific debate and research regarding the timing, the dose and route of administration of exogenous progesterone in ART cycles. For years, the administration of progesterone was based on a "one fits all"- concept, mainly driven from the doctors and patients' preference regarding dose, timing and route of administration of the exogenous progesterone. Due to the lack of solid and evidence-based knowledge, the LPS improving investigating LPS is of outmost importance.
Therefore, improving the LPS is continuously in the focus of research and investigation. Main objectives of those efforts are to clarify the optimal timing, dosage and route of administration of progesterone for every possible ART procedure, in order to improve therapy outcomes. Of special interest in this wide field is the management of LPS in embryo-transfer-cycles such as substituted cycles and modified natural cycles for frozen-thawed cycles, and in fresh embryo-transfers after stimulated cycles.
Measuring serum progesterone levels in the luteal phase of a transfer cycle seems to be a promising approach in resolving the former mentioned doubts. Now, research focuses on luteal-phase serum progesterone levels as a predictor of outcomes. The discovery of certain thresholds of progesterone levels in the serum would give us a handy tool for individualizing the LPS with the main objective to improve outcomes.
Previous studies could show that there exist certain thresholds of serum progesterone in substituted cycles that could be used as a predictor. Furthermore, the same group could show that modifying the dose and the route of administration in the sense of individualizing LPS can improve outcomes.
Considering those results, it remains to clarify if there also exist thresholds of serum progesterone in modified natural cycles and stimulated cycles and if it's possible to improve the results through individualization of LPS the same way as it has been shown for substituted cycles.
The intention of the present study is to carry out the determination of serum progesterone on the day of the embryo transfer to all those patients who are going to be subjected in IVIRMA Valencia to an embryo transfer in a modified natural cycle or a stimulated cycle.
- Conditions
- Infertility, Female
- Being tested
- PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENT
- Keywords
- Progesterone in luteal phase, modified natural cycle, stimulated cycle, clinical pregnancy rate, live birth rate
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENTProcedure or surgery
The only intervention will be a single determination of serum P and E2 levels immediately before the embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| MODIFIED NATURAL CYCLE | The term 'modified natural cycle' refers to a natural cycle in which ovulation is triggered by exogenous hCG administration in order to provide optimal timing scheduling embryo transfer. In contrast to the natural cycle, the applied hCG may lead to a different luteal phase profile. Luteal phase support is common clinical practice in those cycles.
On the day of embryo transfer (ET), eligible patients being transferred one or two good quality embryos on day 5 of development according to the Spanish ASEBIR classification will be informed about the nature of the study, read the informed consent (IC) form and decide if entering into the study. After signing the IC form, a blood test will be performed in a time frame between 1 and 2 hours before the ET.
The only intervention will be a single determination of serum P and E2 levels immediately before the embryo transfer. Receives: Procedure: PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENT | |
| STIMULATED CYCLE | On the day of embryo transfer (ET), eligible patients being transferred one or two good quality embryos on day 5 of development according to the Spanish ASEBIR classification will be informed about the nature of the study, read the informed consent (IC) form and decide if entering into the study. After signing the IC form, a blood test will be performed in a time frame between 1 and 2 hours before the ET.
The only intervention will be a single determination of serum P and E2 levels immediately before the embryo transfer. Receives: Procedure: PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Presence or absence of ongoing pregnancy
Measured: 12 months
Secondary outcomes (3)
Implantation rate
Presence or absence of implantation
Measured: 12 months
Live Birth
Presence or absence of Live Birth
Measured: 12 months
Pregnancy Loss
Presence or absence of pregnancy loss
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start19 Feb 2020
- Primary completion25 Jul 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- 488 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Labarta, MD, Principal investigator, IVIRMA VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259996
- Sponsor's protocol ID
- 1907-VLC-075-EL
- Acronym
- CORPUS-LUTEUM
- Status last verified
- Oct 2023
- First submitted
- 5 Feb 2020
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serum Progesterone Concentration on the Day of Embryo Transfer in Modified Natural Cycles and Stimulated Cycles on Ongoing Pregnancy Rate
- ClinicalTrials.gov ID
- NCT04259996
- Acronym / sponsor ID
- CORPUS-LUTEUM / 1907-VLC-075-EL
- Conditions
- Infertility, Female
- Keywords
- Progesterone in luteal phase, modified natural cycle, stimulated cycle, clinical pregnancy rate, live birth rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 7 Feb 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.
Prospective cohort unicentric study including infertile patients undergoing an embryo transfer in the context of natural or stimulated cycles and receiving luteal phase support with vaginal natural progesterone following the clinical practice in our clinic in IVIRMA Valencia, Spain.
Detailed description
Progesterone as a promoter of endometrial maturation is essential for the process of embryo implantation. The transformation of the endometrium from a proliferative state to a receptive state depends on the adequate progesterone exposure of the endometrium. Therefore, in any assisted reproduction technique (ART) the management of the luteal phase with exogenous administered progesterone, aiming to achieve a receptive endometrial state, is an essential part of the therapy. This important part of infertility-treatment is called luteal phase support (LPS).
Currently, there is a scientific debate and research regarding the timing, the dose and route of administration of exogenous progesterone in ART cycles. For years, the administration of progesterone was based on a "one fits all"- concept, mainly driven from the doctors and patients' preference regarding dose, timing and route of administration of the exogenous progesterone. Due to the lack of solid and evidence-based knowledge, the LPS improving investigating LPS is of outmost importance.
Therefore, improving the LPS is continuously in the focus of research and investigation. Main objectives of those efforts are to clarify the optimal timing, dosage and route of administration of progesterone for every possible ART procedure, in order to improve therapy outcomes. Of special interest in this wide field is the management of LPS in embryo-transfer-cycles such as substituted cycles and modified natural cycles for frozen-thawed cycles, and in fresh embryo-transfers after stimulated cycles.
Measuring serum progesterone levels in the luteal phase of a transfer cycle seems to be a promising approach in resolving the former mentioned doubts. Now, research focuses on luteal-phase serum progesterone levels as a predictor of outcomes. The discovery of certain thresholds of progesterone levels in the serum would give us a handy tool for individualizing the LPS with the main objective to improve outcomes.
Previous studies could show that there exist certain thresholds of serum progesterone in substituted cycles that could be used as a predictor. Furthermore, the same group could show that modifying the dose and the route of administration in the sense of individualizing LPS can improve outcomes.
Considering those results, it remains to clarify if there also exist thresholds of serum progesterone in modified natural cycles and stimulated cycles and if it's possible to improve the results through individualization of LPS the same way as it has been shown for substituted cycles.
The intention of the present study is to carry out the determination of serum progesterone on the day of the embryo transfer to all those patients who are going to be subjected in IVIRMA Valencia to an embryo transfer in a modified natural cycle or a stimulated cycle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MODIFIED NATURAL CYCLE | – | Procedure: PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENTThe term 'modified natural cycle' refers to a natural cycle in which ovulation is triggered by exogenous hCG administration in order to provide optimal timing scheduling embryo transfer. In contrast to the natural cycle, the applied hCG may lead to a different luteal phase profile. Luteal phase support is common clinical practice in those cycles. On the day of embryo transfer (ET), eligible patients being transferred one or two good quality embryos on day 5 of development according to the Spanish ASEBIR classification will be informed about the nature of the study, read the informed consent (IC) form and decide if entering into the study. After signing the IC form, a blood test will be performed in a time frame between 1 and 2 hours before the ET. The only intervention will be a single determination of serum P and E2 levels immediately before the embryo transfer. |
| STIMULATED CYCLE | – | Procedure: PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENTOn the day of embryo transfer (ET), eligible patients being transferred one or two good quality embryos on day 5 of development according to the Spanish ASEBIR classification will be informed about the nature of the study, read the informed consent (IC) form and decide if entering into the study. After signing the IC form, a blood test will be performed in a time frame between 1 and 2 hours before the ET. The only intervention will be a single determination of serum P and E2 levels immediately before the embryo transfer. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All infertile patients undergoing a fresh or frozen blastocyst transfer (two blastocysts transferred as maximum) from own or donated oocytes; in the context of a modified natural cycle (group A) or a stimulated cycle (group B). As usually performed in our daily clinical practice, all patients will receive hCG to trigger ovulation and maintain the corpus luteum to produce endogenous progesterone. Luteal phase support will be given as usual according to the routine in our center.
Key inclusion criteria (5 listed)
- The subject must provide written informed consent prior to any study related procedures
- Women ≤50 years old
- BMI ≤ 40 kg/m2
- Adequate endometrial thickness (>6.5mm) and pattern (Triple A structure) in the proliferative phase
- Regular menstrual cycles
Key exclusion criteria (2 listed)
- Uterine Pathology, adnexal pathology
- Systemic diseases
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 |
|---|---|---|
| PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENTThe only intervention will be a single determination of serum P and E2 levels immediately before the embryo transfer. | Procedure or surgery | MODIFIED NATURAL CYCLE, STIMULATED CYCLE |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 months
Presence or absence of ongoing pregnancy
3 secondary outcomes
Implantation rate
Time frame: 12 months
Live Birth
Time frame: 12 months
Pregnancy Loss
Time frame: 12 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 24 Oct 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.
Elena Labarta, MD principal investigator
IVIRMA VALENCIA
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, Female, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
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 5 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 24 Oct 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 Spain. 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?
Ongoing pregnancy rate (time frame: 12 months). 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 24 Oct 2023.