EndometriosisENDO-FIVNCT05815134
Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation
A study testing blood sample in people with Endometriosis and Cell Free DNA, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Endometriosis is a common benign disease in premenopausal women and causes chronic pelvic pain and infertility. This infertility may be due to pelvic adhesions and surgery but also because of poor oocyte quality. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Endometriosis, Cell Free DNA
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2020to 1 Jul 2025
- Phase
- Interventional
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients eligible medical assistance to procreation who are about to undergo IVF treatment
- aged between 18 and 43 years old
- and who have signed a consent form
Who cannot join
- patients who are not eligible for medical assistance to procreation,
- patients who are followed for other inflammatory disease,
- patients followed for premature ovarian failure or
- patients with a recent story of pelvic infection
Trial locations and contacts
1 site in 1 country.
About this study
Endometriosis is a common benign disease in premenopausal women and causes chronic pelvic pain and infertility. This infertility may be due to pelvic adhesions and surgery but also because of poor oocyte quality. It is known that endometriosis is associated with an increase oxidative stress, wich induce chronic inflammation, deleterious effect for DNA, proteins and can caused cellular death. ROS markers found in follicular fluid or in serum are significatively higher in endometriosis women. The investigators want to dose a marker of apoptosis in infertile women and see if it's significatively higher in serum and in follicular fluid of patients with endometriosis compared to others infertility causes and if it's correlated to oocyte quality and IVF results. Real time PCR will be used to dose cell free DNA in serum and follicular fluid of patients undergoing IVF treatment (endometriosis and infertility due to tubal factor, male infertility or idiopathic cause). Then the investigators will compare cell free DNA rate with oocyte and embryo quality and with pregnancy outcomes in the different group.
- Conditions
- Endometriosis, Cell Free DNA
- Being tested
- blood sample
- Keywords
- Endometriosis, cell free DNA, oocyte quality
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
10ml of blood will be sampled from patients before undergoing IVF treatment, the cell free DNA will be extracted and then quantified by a real time PCR. Another 10ml sample will be drawn the day of oocyte puncture for a new quantification of cell free DNA in plasma and cell free DNA will also be dose in follicular fluid of patients
| Study group | Role | What they receive |
|---|---|---|
| patients with endometriosis | Experimental | Not described Receives: Biological: blood sample |
| others infertility causes | Active comparator | Not described Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
cell free DNA rate in serum in patients before they start IVF stimulation
cell free DNA in serum quantified by real time PCR in patients before they start IVF stimulation
Measured: day 1
cell free DNA rate in follicular fluid the day of punction
cell free DNA in follicular fluid the day of punction
Measured: day 1
Secondary outcomes (7)
number of oocytes reaching the metaphase II
number of oocytes reaching the metaphase II in both groups of patients
Measured: 1 year
fragmentation rate
fragmentation rate
Measured: 1 year
number of cells at day 2
number of cells at day 2
Measured: day 2
number of cells at day 3
number of cells at day 3
Measured: day 3
blastulation rate at day 5 of developement
blastulation rate at day 5 of developement
Measured: day 5
number of clinical pregnancy in both groups
Measured: 1 year
number of live birth in both groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start26 Aug 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2025
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 EndometriosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815134
- Sponsor's protocol ID
- PI2019_843_0087
- Acronym
- ENDO-FIV
- Status last verified
- Nov 2025
- First submitted
- 20 Mar 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
https://dumas.ccsd.cnrs.fr/dumas-03767871v1/file/2022AMIEM032_VANDECANDELAERE_Albane.pdf
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation
- ClinicalTrials.gov ID
- NCT05815134
- Acronym / sponsor ID
- ENDO-FIV / PI2019_843_0087
- Conditions
- Endometriosis, Cell Free DNA
- Keywords
- Endometriosis, cell free DNA, oocyte quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 18 Apr 2023 (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.
Endometriosis is a common benign disease in premenopausal women and causes chronic pelvic pain and infertility. This infertility may be due to pelvic adhesions and surgery but also because of poor oocyte quality. It is known that endometriosis is associated with an increase oxidative stress, wich induce chronic inflammation, deleterious effect for DNA, proteins and can caused cellular death. ROS markers found in follicular fluid or in serum are significatively higher in endometriosis women. The investigators want to dose a marker of apoptosis in infertile women and see if it's significatively higher in serum and in follicular fluid of patients with endometriosis compared to others infertility causes and if it's correlated to oocyte quality and IVF results. Real time PCR will be used to dose cell free DNA in serum and follicular fluid of patients undergoing IVF treatment (endometriosis and infertility due to tubal factor, male infertility or idiopathic cause). Then the investigators will compare cell free DNA rate with oocyte and embryo quality and with pregnancy outcomes in the different group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with endometriosis | Experimental | Biological: blood sample |
| others infertility causes | Active comparator | Biological: blood sample |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients eligible medical assistance to procreation who are about to undergo IVF treatment
- aged between 18 and 43 years old
- and who have signed a consent form
Key exclusion criteria (4 listed)
- patients who are not eligible for medical assistance to procreation,
- patients who are followed for other inflammatory disease,
- patients followed for premature ovarian failure or
- patients with a recent story of pelvic infection
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 |
|---|---|---|
| blood sample10ml of blood will be sampled from patients before undergoing IVF treatment, the cell free DNA will be extracted and then quantified by a real time PCR. Another 10ml sample will be drawn the day of oocyte puncture for a new quantification of cell free DNA in plasma and cell free DNA will also be dose in follicular fluid of patients | Biological | others infertility causes, patients with endometriosis |
Primary outcome
cell free DNA rate in serum in patients before they start IVF stimulation
Time frame: day 1
cell free DNA in serum quantified by real time PCR in patients before they start IVF stimulation
cell free DNA rate in follicular fluid the day of punction
Time frame: day 1
cell free DNA in follicular fluid the day of punction
7 secondary outcomes
number of oocytes reaching the metaphase II
Time frame: 1 year
fragmentation rate
Time frame: 1 year
number of cells at day 2
Time frame: day 2
number of cells at day 3
Time frame: day 3
blastulation rate at day 5 of developement
Time frame: day 5
number of clinical pregnancy in both groups
Time frame: 1 year
number of live birth in both groups
Time frame: 1 year
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 25 Nov 2025.
- Results publicationhttps://dumas.ccsd.cnrs.fr/dumas-03767871v1/file/2022AMIEM032_VANDECANDELAERE_Albane.pdf
- 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?
A study testing blood sample in people with Endometriosis and Cell Free DNA, run by Centre Hospitalier Universitaire, Amiens 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 4 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 25 Nov 2025. 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?
cell free DNA rate in serum in patients before they start IVF stimulation (time frame: day 1). The study lists 2 primary outcomes in all. 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 NCT05815134, 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 25 Nov 2025.