Outcomes of Couples After Failed PGD Management: A Single-Center Study at the Paris PGD Center (Antoine Béclère - Necker)

NCT07371312 | Recruiting

• 2 other identifiers: APHP2509122025-A02124-45
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline

• Continuation of parental project after PGD failure

  Baseline

• Post-PGD pathways followed after failure of PGD care

  From PGD failure to questionnaire completion

• Occurrence of at least one pregnancy after PGD failure

  From PGD failure to questionnaire completion

• Pregnancy occurring at least 3 years after PGD failure

  At least 3 years after PGD failure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• One or more live-born children resulting from PGD care in the center.
• PGD involving gamete donation.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Antoine Béclère

Clamart, 92140, France

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Charlotte SONIGO, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte SONIGO, PhD

CONTACT

00 33 1 45 37 47 68; charlotte.sonigo@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 27, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): March 25, 2028
• Study Completion (Estimated): March 25, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (1)