- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468331
Egg Donation at the Assisted Reproductive Technology (ART) Center of the Nancy University Hospital (DONOVO-Nancy)
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
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Caroline AIMONE-VIANNA, PHD Medicine
- Phone Number: +33631785041
- Email: c.aimonevianna@chru-nancy.fr
Study Locations
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Nancy, France
- University Hospital of Nancy (CHRU Nancy)
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Contact:
- Caroline AIMONE-VIANNA
- Phone Number: +33631785041
- Email: c.aimonevianna@chru-nancy.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Candidates for egg donation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of donor candidates undergoing oocyte retrieval
Time Frame: From the first biological consultation until oocyte retrieval, assessed up to 12 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Total number of oocytes collected during transvaginal oocyte retrieval divided by the number of retrieval procedures performed.
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At the time of oocyte retrieval procedure, approximately 14-16 days after the start of ovarian stimulation
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Mean time from first biological consultation to oocyte retrieval
Time Frame: From the first biological consultation until oocyte retrieval, assessed up to 12 months
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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.
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From the first biological consultation until oocyte retrieval, assessed up to 12 months
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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
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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.
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At the time of oocyte retrieval procedure, approximately 14-16 days after the start of ovarian stimulation
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Fertilization rate following in vitro fertilization or intracytoplasmic sperm injection
Time Frame: 1 day after fertilization
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Proportion of normally fertilized oocytes (two pronuclei) among the total number of inseminated or injected mature oocytes.
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1 day after fertilization
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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
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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.
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From embryo transfer until confirmation of clinical pregnancy by ultrasound, assessed up to 8 weeks after embryo transfer
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Live birth rate following oocyte donation cycles
Time Frame: From embryo transfer until delivery, assessed up to 41 weeks of gestation
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Proportion of embryo transfer cycles resulting in at least one live birth.
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From embryo transfer until delivery, assessed up to 41 weeks of gestation
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean age of donor candidates
Time Frame: Baseline (at first biological consultation)
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Age of women evaluated for oocyte donation at the time of the first biological consultation.
Results will be summarized using mean and median values.
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Baseline (at first biological consultation)
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Mean body mass index of donor candidates
Time Frame: Baseline (at first biological consultation)
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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.
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Baseline (at first biological consultation)
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Anti-Müllerian hormone level of donor candidates
Time Frame: Baseline (at first biological consultation)
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Serum anti-Müllerian hormone (AMH) level measured in ng/mL at the time of the first biological consultation.
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Baseline (at first biological consultation)
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Antral follicle count of donor candidates
Time Frame: Baseline (at first biological consultation)
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Number of antral follicles measured by transvaginal ultrasound during the initial evaluation for oocyte donation.
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Baseline (at first biological consultation)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2026PI052
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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