Egg Donation at the Assisted Reproductive Technology (ART) Center of the Nancy University Hospital
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-38
SponsorCentral Hospital, Nancy, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All women who attended a biological consultation for primary or secondary oocyte donation at Nancy University Hospital during the study period.
Disqualifiers
Absence of biological consultation for oocyte donation during the study period ;
Insufficient or missing medical data ;
Documented opposition to data use for research purposes.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: Candidates for egg donation
Trial outcomes
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).
Time frame
From the first biological consultation until oocyte retrieval, assessed up to 12 monthsSecondary outcomes
1
Mean number of oocytes retrieved per oocyte retrieval procedure
Total number of oocytes collected during transvaginal oocyte retrieval divided by the number of retrieval procedures performed.
Time frame
At the time of oocyte retrieval procedure, approximately 14-16 days after the start of ovarian stimulation2
Mean time from first biological consultation to oocyte retrieval
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.
Time frame
From the first biological consultation until oocyte retrieval, assessed up to 12 months3
Median number of mature oocytes (metaphase II) retrieved per donor
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.
Time frame
At the time of oocyte retrieval procedure, approximately 14-16 days after the start of ovarian stimulation4
Fertilization rate following in vitro fertilization or intracytoplasmic sperm injection
Proportion of normally fertilized oocytes (two pronuclei) among the total number of inseminated or injected mature oocytes.
Time frame
1 day after fertilizationOther outcomes
1
Mean age of donor candidates
Age of women evaluated for oocyte donation at the time of the first biological consultation. Results will be summarized using mean and median values.
Time frame
Baseline (at first biological consultation)2
Mean body mass index of donor candidates
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.
Time frame
Baseline (at first biological consultation)3
Anti-Müllerian hormone level of donor candidates
Serum anti-Müllerian hormone (AMH) level measured in ng/mL at the time of the first biological consultation.
Time frame
Baseline (at first biological consultation)4
Antral follicle count of donor candidates
Number of antral follicles measured by transvaginal ultrasound during the initial evaluation for oocyte donation.
Time frame
Baseline (at first biological consultation)Sponsors and contacts
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Source ClinicalTrials.gov
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