NCT07468331

Brief Summary

Since the 2021 revision of French bioethics laws, access to assisted reproductive technologies (ART) has expanded, leading to a significant increase in gamete donation requests. In this context, oocyte donation remains a limited resource, with marked disparities between centers and persistent donor shortages. At the Assisted Reproductive Technology Center of Nancy University Hospital, more than fifty women have initiated an oocyte donation process since the implementation of the new legislation. However, not all candidates complete the donation pathway, and clinical and organizational outcomes have not yet been formally evaluated. This retrospective observational study will evaluate the oocyte donation pathway at the Assisted Reproductive Technology Center of Nancy University Hospital. The study population will include all women who attended a biological consultation for primary or secondary oocyte donation from the implementation of the new Bioethics laws until December 31, 2025 (study period). Baseline clinical and biological characteristics of donor candidates will be described, including age, body mass index, anti-Müllerian hormone level, and antral follicle count. The proportion of donor candidates undergoing oocyte retrieval and the time interval between the first biological consultation and oocyte retrieval will be assessed. Biological and clinical outcomes will also be analyzed, including the number of oocytes retrieved, the number of mature oocytes (metaphase II) obtained, fertilization rate following in vitro fertilization, clinical pregnancy rate per embryo transfer, and live birth rate. Results will be compared with national data reported by the French Biomedicine Agency in order to evaluate the activity and outcomes of the center and to identify potential areas for organizational and clinical improvement in the oocyte donation pathway. The overall objective is to optimize donor management and improve access to oocyte donation for recipient patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

March 2, 2026

Last Update Submit

March 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of donor candidates undergoing oocyte retrieval

    Proportion of patients who underwent oocyte retrieval following ovarian stimulation among all donor candidates who attended a biological consultation for oocyte donation at Nancy University Hospital during the study period. The outcome will be reported as a percentage (number of oocyte retrieval procedures divided by the total number of donor candidates evaluated).

    From the first biological consultation until oocyte retrieval, assessed up to 12 months

Secondary Outcomes (6)

  • Mean number of oocytes retrieved per oocyte retrieval procedure

    At the time of oocyte retrieval procedure, approximately 14-16 days after the start of ovarian stimulation

  • Mean time from first biological consultation to oocyte retrieval

    From the first biological consultation until oocyte retrieval, assessed up to 12 months

  • Median number of mature oocytes (metaphase II) retrieved per donor

    At the time of oocyte retrieval procedure, approximately 14-16 days after the start of ovarian stimulation

  • Fertilization rate following in vitro fertilization or intracytoplasmic sperm injection

    1 day after fertilization

  • Clinical pregnancy rate per embryo transfer

    From embryo transfer until confirmation of clinical pregnancy by ultrasound, assessed up to 8 weeks after embryo transfer

  • +1 more secondary outcomes

Other Outcomes (4)

  • Mean age of donor candidates

    Baseline (at first biological consultation)

  • Mean body mass index of donor candidates

    Baseline (at first biological consultation)

  • Anti-Müllerian hormone level of donor candidates

    Baseline (at first biological consultation)

  • +1 more other outcomes

Study Arms (1)

Candidates for egg donation

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population includes all women evaluated for primary or secondary oocyte donation at Nancy University Hospital during the study period. All candidates who attended a biological consultation and initiated the donation assessment process are included, irrespective of donation completion status.

You may qualify if:

  • All women who attended a biological consultation for primary or secondary oocyte donation at Nancy University Hospital during the study period.

You may not qualify if:

  • Absence of biological consultation for oocyte donation during the study period ;
  • Insufficient or missing medical data ;
  • Documented opposition to data use for research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Nancy (CHRU Nancy)

Nancy, France

Location

Central Study Contacts

Caroline AIMONE-VIANNA, PHD Medicine

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in Medicine - Hospital physician

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 12, 2026

Study Start

March 1, 2026

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations