InfertilityDECOPINCT07371312
Outcomes of Couples After Failed PGD Management: A Single-Center Study at the Paris PGD Center (Antoine Béclère - Necker)
An observational study of Infertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Preimplantation genetic testing (PGT) is a reproductive genetic technique aimed at preventing the transmission of severe genetic disorders. In France, its use is strictly regulated and reserved for complex medical situations, often associated with challenging reproductive histories and significant psychological… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- How many people
- 900 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2026to 25 Mar 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
- No healthy volunteers
- Adult, Older adult
Study population: Women belonging to couples managed for preimplantation genetic diagnosis (PGD) at the Paris PGD center (Hôpital Antoine Béclère - Necker, AP-HP) between 2006 and 2022, whose PGD care was discontinued without resulting in a live birth. Couples are identified from an institutional PGD database. All PGD indications are eligible.
Who may be able to join
- Woman belonging to a couple who initiated at least one ovarian stimulation cycle for IVF (± ICSI) with preimplantation genetic diagnosis (PGD).
- No further PGD-related procedures (oocyte retrieval or embryo transfer) performed in the center after December 31, 2022.
- No live-born child resulting from PGD care.
- Woman who expressed her free and informed non-opposition to participation.
Who cannot join
- One or more live-born children resulting from PGD care in the center.
- PGD involving gamete donation.
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
Hôpital Antoine Béclère
Clamart, 92140
Charlotte SONIGO, 06 20 64 13 06, Charlotte.sonigo@aphp.fr
About this study
Preimplantation genetic testing (PGT) is a reproductive genetic technique aimed at preventing the transmission of severe genetic disorders. In France, its use is strictly regulated and reserved for complex medical situations, often associated with challenging reproductive histories and significant psychological burden.
Despite scientific advances, success rates in preimplantation genetic testing remain limited, making the care pathway a significant source of uncertainty regarding the future of the parental project.
Read the detailed description
Preimplantation genetic testing (PGT) is a genetic diagnostic procedure performed on one or a few cells biopsied from embryos created through in vitro fertilization (IVF), prior to uterine transfer. The primary aim of PGT is to enable couples at confirmed risk of transmitting a genetic or chromosomal disorder considered to be of particular severity to have a child unaffected by the condition. By offering this possibility, PGT also represents an alternative to prenatal diagnosis (PND) and helps reduce the use of medical termination of pregnancy (MTP) when fetal abnormalities are detected.
In France, PGT is strictly regulated by bioethics laws and the Public Health Code (Article L2131-4). It is authorized only on an exceptional basis, under conditions defined by legislation, for couples at risk of transmitting a serious genetic disorder recognized as incurable at the time of diagnosis (Agence de la biomédecine, 2023). This regulatory framework aims to ensure the ethical and controlled use of this technology. Introduced in France in 1999, PGT is currently performed in only five multidisciplinary centers authorized by the Agence de la biomédecine (ABM): Grenoble, Montpellier, Nantes, Paris, and Strasbourg.
Indications for PGT are diverse and reflect a wide range of medical and familial contexts. They include histories of recurrent pregnancy loss, multiple medical terminations of pregnancy, the presence of a severe genetic disorder in one member of the couple or their offspring, as well as situations in which relatives have been diagnosed with a serious disease or disability, sometimes with late onset. These circumstances are often associated with complex psychological experiences, marked by repeated trauma and high levels of stress. In this context, psychological support is essential throughout the procedure to help couples manage uncertainty and potential treatment failure.
Moreover, despite technological advances, success rates of PGT remain limited. Consequently, the assisted reproductive technology pathway involving PGT represents a major source of stress and may generate significant distress and uncertainty for couples. This process affects individuals on multiple levels: personal, relational, familial, and societal. A better understanding of these factors may allow clinical interventions to be adapted in order to more effectively support couples throughout their care pathway. When the PGT process does not result in the birth of a child, couples are faced with difficult decisions regarding the continuation of their parental project. Several options may then be considered: (i) attempting a natural pregnancy, with or without prenatal diagnosis; (ii) seeking PGT treatment abroad; (iii) considering gamete donation; or (iv) opting for adoption. In some cases, couples choose to discontinue their parental project altogether. Although these trajectories are individual, they are often influenced by medical, social, economic, and psychological factors.
- Conditions
- Infertility
- Keywords
- Preimplantation Genetic Diagnosis, Assisted Reproductive Technology, Infertility, Reproductive Outcomes, Live Birth, Pregnancy Outcome, Parental Project, Post-treatment Reproductive Pathways, Long-term Outcomes, Couples Reproductive Decisions
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of couples with at least one live-born child surviving ≥3 years after failure of preimplantation genetic diagnosis (PGD)
Proportion of couples who achieved at least one pregnancy resulting in the birth of a live child who was alive at the age of 3 years or more, following failure of PGD care. PGD failure is defined as the absence of a live-born child resulting from PGD performed in the center. Outcome is assessed based on self-reported data collected via questionnaire, with verification when necessary.
Measured: At least 3 years after the failure of PGD care (date of last PGD-related medical procedure in the center)
Secondary outcomes (6)
Reason for discontinuation of preimplantation genetic diagnosis (PGD) care
Proportion of couples according to the reason for discontinuation of PGD care (medical decision vs couple's decision), assessed using a self-administered questionnaire.
Measured: Baseline
Continuation of parental project after PGD failure
Proportion of couples who continued or discontinued their parental project after PGD failure, assessed using a self-administered questionnaire.
Measured: Baseline
Post-PGD pathways followed after failure of PGD care
Description of pathways undertaken after PGD failure, including natural conception attempts, assisted reproductive technology without PGD, PGD in another center, adoption, or abandonment of the parental project, and their outcomes.
Measured: From PGD failure to questionnaire completion
Occurrence of at least one pregnancy after PGD failure
Proportion of couples who achieved at least one pregnancy, whether evolutive or not, after failure of PGD care, regardless of the pathway followed.
Measured: From PGD failure to questionnaire completion
Pregnancy occurring at least 3 years after PGD failure
Occurrence and date of onset of any pregnancy (evolutive or not) that occurred at least 3 years after the failure of PGD care.
Measured: At least 3 years after PGD failure
Time to first pregnancy after PGD failure
Time interval between the date of the last PGD-related medical procedure performed in the center and the date of onset of the first pregnancy (evolutive or not) obtained after PGD failure.
Measured: From PGD failure to date of first pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start25 Mar 2026
- Primary completion25 Mar 2028 (estimated)
- Study completion25 Mar 2028 (estimated)
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 Assistance Publique - Hôpitaux de ParisThe 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte SONIGO, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371312
- Sponsor's protocol ID
- APHP250912
- Other IDs
- 2025-A02124-45
- Acronym
- DECOPI
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Couples After Failed PGD Management: A Single-Center Study at the Paris PGD Center (Antoine Béclère - Necker)
- ClinicalTrials.gov ID
- NCT07371312
- Acronym / sponsor ID
- DECOPI / APHP250912
- Conditions
- Infertility
- Keywords
- Preimplantation Genetic Diagnosis, Assisted Reproductive Technology, Infertility, Reproductive Outcomes, Live Birth, Pregnancy Outcome, Parental Project, Post-treatment Reproductive Pathways
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 25 Mar 2028 (estimated)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 27 Jan 2026 (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.
Preimplantation genetic testing (PGT) is a reproductive genetic technique aimed at preventing the transmission of severe genetic disorders. In France, its use is strictly regulated and reserved for complex medical situations, often associated with challenging reproductive histories and significant psychological burden.
Despite scientific advances, success rates in preimplantation genetic testing remain limited, making the care pathway a significant source of uncertainty regarding the future of the parental project.
Detailed description
Preimplantation genetic testing (PGT) is a genetic diagnostic procedure performed on one or a few cells biopsied from embryos created through in vitro fertilization (IVF), prior to uterine transfer. The primary aim of PGT is to enable couples at confirmed risk of transmitting a genetic or chromosomal disorder considered to be of particular severity to have a child unaffected by the condition. By offering this possibility, PGT also represents an alternative to prenatal diagnosis (PND) and helps reduce the use of medical termination of pregnancy (MTP) when fetal abnormalities are detected.
In France, PGT is strictly regulated by bioethics laws and the Public Health Code (Article L2131-4). It is authorized only on an exceptional basis, under conditions defined by legislation, for couples at risk of transmitting a serious genetic disorder recognized as incurable at the time of diagnosis (Agence de la biomédecine, 2023). This regulatory framework aims to ensure the ethical and controlled use of this technology. Introduced in France in 1999, PGT is currently performed in only five multidisciplinary centers authorized by the Agence de la biomédecine (ABM): Grenoble, Montpellier, Nantes, Paris, and Strasbourg.
Indications for PGT are diverse and reflect a wide range of medical and familial contexts. They include histories of recurrent pregnancy loss, multiple medical terminations of pregnancy, the presence of a severe genetic disorder in one member of the couple or their offspring, as well as situations in which relatives have been diagnosed with a serious disease or disability, sometimes with late onset. These circumstances are often associated with complex psychological experiences, marked by repeated trauma and high levels of stress. In this context, psychological support is essential throughout the procedure to help couples manage uncertainty and potential treatment failure.
Moreover, despite technological advances, success rates of PGT remain limited. Consequently, the assisted reproductive technology pathway involving PGT represents a major source of stress and may generate significant distress and uncertainty for couples. This process affects individuals on multiple levels: personal, relational, familial, and societal. A better understanding of these factors may allow clinical interventions to be adapted in order to more effectively support couples throughout their care pathway. When the PGT process does not result in the birth of a child, couples are faced with difficult decisions regarding the continuation of their parental project. Several options may then be considered: (i) attempting a natural pregnancy, with or without prenatal diagnosis; (ii) seeking PGT treatment abroad; (iii) considering gamete donation; or (iv) opting for adoption. In some cases, couples choose to discontinue their parental project altogether. Although these trajectories are individual, they are often influenced by medical, social, economic, and psychological factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women belonging to couples managed for preimplantation genetic diagnosis (PGD) at the Paris PGD center (Hôpital Antoine Béclère - Necker, AP-HP) between 2006 and 2022, whose PGD care was discontinued without resulting in a live birth. Couples are identified from an institutional PGD database. All PGD indications are eligible.
Key inclusion criteria (4 listed)
- Woman belonging to a couple who initiated at least one ovarian stimulation cycle for IVF (± ICSI) with preimplantation genetic diagnosis (PGD).
- No further PGD-related procedures (oocyte retrieval or embryo transfer) performed in the center after December 31, 2022.
- No live-born child resulting from PGD care.
- Woman who expressed her free and informed non-opposition to participation.
Key exclusion criteria (2 listed)
- One or more live-born children resulting from PGD care in the center.
- PGD involving gamete donation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of couples with at least one live-born child surviving ≥3 years after failure of preimplantation genetic diagnosis (PGD)
Time frame: At least 3 years after the failure of PGD care (date of last PGD-related medical procedure in the center)
Proportion of couples who achieved at least one pregnancy resulting in the birth of a live child who was alive at the age of 3 years or more, following failure of PGD care. PGD failure is defined as the absence of a live-born child resulting from PGD performed in the center. Outcome is assessed based on self-reported data collected via questionnaire, with verification when necessary.
6 secondary outcomes
Reason for discontinuation of preimplantation genetic diagnosis (PGD) care
Time frame: Baseline
Continuation of parental project after PGD failure
Time frame: Baseline
Post-PGD pathways followed after failure of PGD care
Time frame: From PGD failure to questionnaire completion
Occurrence of at least one pregnancy after PGD failure
Time frame: From PGD failure to questionnaire completion
Pregnancy occurring at least 3 years after PGD failure
Time frame: At least 3 years after PGD failure
Time to first pregnancy after PGD failure
Time frame: From PGD failure to date of first pregnancy
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 21 Apr 2026.
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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.
Charlotte SONIGO, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Assistance Publique - Hôpitaux de Paris 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 4 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: looking for participants now, as of the sponsor's last update on 21 Apr 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 Charlotte SONIGO, PhD (00 33 1 45 37 47 68, charlotte.sonigo@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of couples with at least one live-born child surviving ≥3 years after failure of preimplantation genetic diagnosis (PGD) (time frame: At least 3 years after the failure of PGD care (date of last PGD-related medical procedure in the center)). 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 21 Apr 2026.