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NCT Number: NCT07468331

Egg Donation at the Assisted Reproductive Technology (ART) Center of the Nancy University Hospital

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.

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Key information

Conditions

Egg Donation Infertility Assisted Reproductive Technology

Age range

18 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Proportion of donor candidates undergoing oocyte retrieval

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

    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).

Secondary outcomes

  1. Mean number of oocytes retrieved per oocyte retrieval procedure

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

    Total number of oocytes collected during transvaginal oocyte retrieval divided by the number of retrieval procedures performed.

  2. Mean time from first biological consultation to oocyte retrieval

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

    Mean time interval between the first biological consultation for oocyte donation and the oocyte retrieval procedure among donor candidates who completed ovarian stimulation and underwent oocyte retrieval. The time interval will be calculated in months.

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

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

    Median number of mature oocytes at the metaphase II stage obtained per oocyte retrieval procedure. Only oocytes classified as metaphase II at the time of assessment in the embryology laboratory will be included in the calculation.

  4. Fertilization rate following in vitro fertilization or intracytoplasmic sperm injection

    Time frame: 1 day after fertilization

    Proportion of normally fertilized oocytes (two pronuclei) among the total number of inseminated or injected mature oocytes.

  5. Clinical pregnancy rate per embryo transfer

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

    Proportion of embryo transfer cycles resulting in a clinical pregnancy defined as the presence of an intrauterine gestational sac with fetal heartbeat detected by ultrasound.

  6. Live birth rate following oocyte donation cycles

    Time frame: From embryo transfer until delivery, assessed up to 41 weeks of gestation

    Proportion of embryo transfer cycles resulting in at least one live birth.

Other outcomes

  1. Mean age of donor candidates

    Time frame: Baseline (at first biological consultation)

    Age of women evaluated for oocyte donation at the time of the first biological consultation. Results will be summarized using mean and median values.

  2. Mean body mass index of donor candidates

    Time frame: Baseline (at first biological consultation)

    Body Mass Index calculated from weight (kg) and height (m) recorded at the time of the first biological consultation, using the standard formula: BMI = weight (kg) / height (m²). BMI will be reported in kg/m².

  3. Anti-Müllerian hormone level of donor candidates

    Time frame: Baseline (at first biological consultation)

    Serum anti-Müllerian hormone (AMH) level measured in ng/mL at the time of the first biological consultation.

  4. Antral follicle count of donor candidates

    Time frame: Baseline (at first biological consultation)

    Number of antral follicles measured by transvaginal ultrasound during the initial evaluation for oocyte donation.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline AIMONE-VIANNA, PHD Medicine

CONTACT

[email protected]

+33631785041

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

DONOVO-Nancy: Egg Donation at the Assisted Reproductive Technology (ART) Center of the Nancy University Hospital: an Overview of the Donor Journey Since the Revisions to the Bioethics Laws

Acronym: DONOVO-Nancy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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