Pregnant WomenCellF-CervixNCT06523543
Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells
An observational study of Pregnant Women, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Inclusion (Visit 1 - Week 7-16), Second semester of pregnancy (Visit 2 - Week 20-24) and Third semester of pregnancy (Visit 3- Week 34)
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2024to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women with a priori genetic risk
Who may be able to join
- Pregnant woman
- Singleton pregnancy
- Pregnancy between 7 and 16 weeks of amenorrhea (WA)
- Woman ≥ 18 years
- Woman who has signed an informed consent
- Woman affiliated to social security or equivalent scheme
Show all 10Show fewer
- Exclusions Criteria:
- Person under guardianship or curatorship
- Person placed under legal protection
- Person unable to provide the participant with informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier
Montpellier, France, 34295
Vincent GATINOIS, Dr
About this study
Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.
Read the detailed description
During pregnancy, biological screening for genetic diseases of the fetus cannot be implemented before the 11th week of amenorrhea whatever the technique used. This delay is long and distressing, particularly for people at high risk of transmission of genetic diseases. The presence of extravillous trophoblast cells to the cervix of the pregnant woman from the 7th week, accessible by a cervicovaginal smear non-invasive, represents new biological material representative of the fetal genome. This project aimed at evaluating the performance of a method for analyzing these trophoblast cells extra-villous at the start of pregnancy. The investigators want to evaluate performance analytical aspects of this method, that is to say, verifying that the genetic information resulting from these cells correspond to those of the fetus.
- Conditions
- Pregnant Women
- Being tested
- Inclusion (Visit 1 - Week 7-16), Second semester of pregnancy (Visit 2 - Week 20-24), Third semester of pregnancy (Visit 3- Week 34)
- Keywords
- Trophoblast cells, Endocervical canal, Fluorescent in situ hybridization (FISH), Non-invasive prenatal test, Fetal gender
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclusion (Visit 1 - Week 7-16)Procedure or surgery
Extraction of cervico-vaginal sampling
Second semester of pregnancy (Visit 2 - Week 20-24)Diagnostic test
Ultrasound examination (determination of chromosomal sex)
Third semester of pregnancy (Visit 3- Week 34)Diagnostic test
Ultrasound examination (determination of chromosomal sex) if this has not be done during the Visit 2 or if a new determination correcting the previous one is provided.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Women who are pregnant between 7 and 16 weeks of amenorrhea (WA) Receives: Procedure: Inclusion (Visit 1 - Week 7-16); Diagnostic Test: Second semester of pregnancy (Visit 2 - Week 20-24); Diagnostic Test: Third semester of pregnancy (Visit 3- Week 34) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish an ultra-early detection method
Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography
Measured: Visit 2 (Week 20-24)
Secondary outcomes (2)
Evaluate the ability of the method to provide a result in the context of a progressive pregnancy
- Time (minutes) elapsed between sampling and biological validation of the result
- Number of trophoblast cells identified
- Failure rate: number of samples for which biological signals were not successful to determine the fetal chromosomal sex
Measured: Visit 2 (Week 20-24)
Expected benefit of ultra-early cytogenetic information
Evaluate the ability of the method to provide a rapid result and evaluate the impact of information about pregnant women
Measured: Visit 2 (Week 20-24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start19 Nov 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent GATINOIS, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523543
- Sponsor's protocol ID
- RECHMPL23_0417
- Acronym
- CellF-Cervix
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bailey-Hytholt CM, Sayeed S, Kraus M, Joseph R, Shukla A, Tripathi A. A Rapid Method for Label-Free Enrichment of Rare Trophoblast Cells from Cervical Samples. Sci Rep. 2019 Aug 20;9(1):12115. doi: 10.1038/s41598-019-48346-3.
PubMed 31431640Bolnick JM, Kilburn BA, Bajpayee S, Reddy N, Jeelani R, Crone B, Simmerman N, Singh M, Diamond MP, Armant DR. Trophoblast retrieval and isolation from the cervix (TRIC) for noninvasive prenatal screening at 5 to 20 weeks of gestation. Fertil Steril. 2014 Jul;102(1):135-142.e6. doi: 10.1016/j.fertnstert.2014.04.008. Epub 2014 May 10.
PubMed 24825422Drewlo S, Armant DR. Quo vadis, trophoblast? Exploring the new ways of an old cell lineage. Placenta. 2017 Dec;60 Suppl 1(Suppl 1):S27-S31. doi: 10.1016/j.placenta.2017.04.021. Epub 2017 Apr 26.
PubMed 28483162Fritz R, Kohan-Ghadr HR, Bolnick JM, Bolnick AD, Kilburn BA, Diamond MP, Drewlo S, Armant DR. Noninvasive detection of trophoblast protein signatures linked to early pregnancy loss using trophoblast retrieval and isolation from the cervix (TRIC). Fertil Steril. 2015 Aug;104(2):339-46.e4. doi: 10.1016/j.fertnstert.2015.05.010. Epub 2015 Jun 11.
PubMed 26051097Kadam L, Jain C, Kohan-Ghadr HR, Krawetz SA, Drewlo S, Armant DR. Endocervical trophoblast for interrogating the fetal genome and assessing pregnancy health at five weeks. Eur J Med Genet. 2019 Aug;62(8):103690. doi: 10.1016/j.ejmg.2019.103690. Epub 2019 Jun 18.
PubMed 31226440Mantzaris D, Cram DS. Potential of syncytiotrophoblasts isolated from the cervical mucus for early non-invasive prenatal diagnosis: evidence of a vanishing twin. Clin Chim Acta. 2015 Jan 1;438:309-15. doi: 10.1016/j.cca.2014.09.002. Epub 2014 Sep 8.
PubMed 25218787Moser G, Drewlo S, Huppertz B, Armant DR. Trophoblast retrieval and isolation from the cervix: origins of cervical trophoblasts and their potential value for risk assessment of ongoing pregnancies. Hum Reprod Update. 2018 Jul 1;24(4):484-496. doi: 10.1093/humupd/dmy008.
PubMed 29608700Pfeifer I, Benachi A, Saker A, Bonnefont JP, Mouawia H, Broncy L, Frydman R, Brival ML, Lacour B, Dachez R, Paterlini-Brechot P. Cervical trophoblasts for non-invasive single-cell genotyping and prenatal diagnosis. Placenta. 2016 Jan;37:56-60. doi: 10.1016/j.placenta.2015.11.002. Epub 2015 Nov 11.
PubMed 26680636Shettles LB. Use of the Y chromosome in prenatal sex determination. Nature. 1971 Mar 5;230(5288):52-3. doi: 10.1038/230052b0. No abstract available.
PubMed 4102825
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells
- ClinicalTrials.gov ID
- NCT06523543
- Acronym / sponsor ID
- CellF-Cervix / RECHMPL23_0417
- Conditions
- Pregnant Women
- Keywords
- Trophoblast cells, Endocervical canal, Fluorescent in situ hybridization (FISH), Non-invasive prenatal test, Fetal gender
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 26 Jul 2024 (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.
Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.
Detailed description
During pregnancy, biological screening for genetic diseases of the fetus cannot be implemented before the 11th week of amenorrhea whatever the technique used. This delay is long and distressing, particularly for people at high risk of transmission of genetic diseases. The presence of extravillous trophoblast cells to the cervix of the pregnant woman from the 7th week, accessible by a cervicovaginal smear non-invasive, represents new biological material representative of the fetal genome. This project aimed at evaluating the performance of a method for analyzing these trophoblast cells extra-villous at the start of pregnancy. The investigators want to evaluate performance analytical aspects of this method, that is to say, verifying that the genetic information resulting from these cells correspond to those of the fetus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Procedure: Inclusion (Visit 1 - Week 7-16), Diagnostic Test: Second semester of pregnancy (Visit 2 - Week 20-24), Diagnostic Test: Third semester of pregnancy (Visit 3- Week 34)Women who are pregnant between 7 and 16 weeks of amenorrhea (WA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with a priori genetic risk
Key inclusion criteria (10 listed)
- Pregnant woman
- Singleton pregnancy
- Pregnancy between 7 and 16 weeks of amenorrhea (WA)
- Woman ≥ 18 years
- Woman who has signed an informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Inclusion (Visit 1 - Week 7-16)Extraction of cervico-vaginal sampling | Procedure or surgery | Pregnant women |
| Second semester of pregnancy (Visit 2 - Week 20-24)Ultrasound examination (determination of chromosomal sex) | Diagnostic test | Pregnant women |
| Third semester of pregnancy (Visit 3- Week 34)Ultrasound examination (determination of chromosomal sex) if this has not be done during the Visit 2 or if a new determination correcting the previous one is provided. | Diagnostic test | Pregnant women |
Primary outcome
Establish an ultra-early detection method
Time frame: Visit 2 (Week 20-24)
Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography
2 secondary outcomes
Evaluate the ability of the method to provide a result in the context of a progressive pregnancy
Time frame: Visit 2 (Week 20-24)
Expected benefit of ultra-early cytogenetic information
Time frame: Visit 2 (Week 20-24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 31431640Bailey-Hytholt CM, Sayeed S, Kraus M, Joseph R, Shukla A, Tripathi A. A Rapid Method for Label-Free Enrichment of Rare Trophoblast Cells from Cervical Samples. Sci Rep. 2019 Aug 20;9(1):12115. doi: 10.1038/s41598-019-48346-3.
- Background: PubMed 24825422Bolnick JM, Kilburn BA, Bajpayee S, Reddy N, Jeelani R, Crone B, Simmerman N, Singh M, Diamond MP, Armant DR. Trophoblast retrieval and isolation from the cervix (TRIC) for noninvasive prenatal screening at 5 to 20 weeks of gestation. Fertil Steril. 2014 Jul;102(1):135-142.e6. doi: 10.1016/j.fertnstert.2014.04.008. Epub 2014 May 10.
- Background: PubMed 28483162Drewlo S, Armant DR. Quo vadis, trophoblast? Exploring the new ways of an old cell lineage. Placenta. 2017 Dec;60 Suppl 1(Suppl 1):S27-S31. doi: 10.1016/j.placenta.2017.04.021. Epub 2017 Apr 26.
- Background: PubMed 26051097Fritz R, Kohan-Ghadr HR, Bolnick JM, Bolnick AD, Kilburn BA, Diamond MP, Drewlo S, Armant DR. Noninvasive detection of trophoblast protein signatures linked to early pregnancy loss using trophoblast retrieval and isolation from the cervix (TRIC). Fertil Steril. 2015 Aug;104(2):339-46.e4. doi: 10.1016/j.fertnstert.2015.05.010. Epub 2015 Jun 11.
- Background: PubMed 31226440Kadam L, Jain C, Kohan-Ghadr HR, Krawetz SA, Drewlo S, Armant DR. Endocervical trophoblast for interrogating the fetal genome and assessing pregnancy health at five weeks. Eur J Med Genet. 2019 Aug;62(8):103690. doi: 10.1016/j.ejmg.2019.103690. Epub 2019 Jun 18.
- Background: PubMed 25218787Mantzaris D, Cram DS. Potential of syncytiotrophoblasts isolated from the cervical mucus for early non-invasive prenatal diagnosis: evidence of a vanishing twin. Clin Chim Acta. 2015 Jan 1;438:309-15. doi: 10.1016/j.cca.2014.09.002. Epub 2014 Sep 8.
- Background: PubMed 29608700Moser G, Drewlo S, Huppertz B, Armant DR. Trophoblast retrieval and isolation from the cervix: origins of cervical trophoblasts and their potential value for risk assessment of ongoing pregnancies. Hum Reprod Update. 2018 Jul 1;24(4):484-496. doi: 10.1093/humupd/dmy008.
- Background: PubMed 26680636Pfeifer I, Benachi A, Saker A, Bonnefont JP, Mouawia H, Broncy L, Frydman R, Brival ML, Lacour B, Dachez R, Paterlini-Brechot P. Cervical trophoblasts for non-invasive single-cell genotyping and prenatal diagnosis. Placenta. 2016 Jan;37:56-60. doi: 10.1016/j.placenta.2015.11.002. Epub 2015 Nov 11.
- Background: PubMed 4102825Shettles LB. Use of the Y chromosome in prenatal sex determination. Nature. 1971 Mar 5;230(5288):52-3. doi: 10.1038/230052b0. No abstract available.
Related trials for Pregnant Women
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Vincent GATINOIS, MD principal investigator
University Hospital, Montpellier
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 Pregnant Women, run by University Hospital, Montpellier 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 10 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent GATINOIS, MD (0 67 33 68 66, v-gatinois@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish an ultra-early detection method (time frame: Visit 2 (Week 20-24)). 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 NCT06523543, which also lists 9 linked publications.
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 13 Mar 2026.