- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07312058
Long-term Evaluation of Fertility Preservation Options in Women in Cancer Remission or Haematological Pathology (FERT-ISSUES)
Cancer treatments, despite their increasing effectiveness, carry a significant risk of gamete toxicity.
Women of reproductive age are commonly offered fertility preservation (FP) before starting their treatment.
However, few studies have analyzed the long-term reproductive outcomes of these interventions, nor how patients ultimately use or do not use the FP options once in remission.
This project aims to better understand the effectiveness, utilization, and psychological impacts of these strategies.
This work is part of an effort to understand and evaluate fertility preservation practices implemented for women of reproductive age undergoing cancer treatment at the Amiens-Picardie University Hospital (CHU).
Its objective is to document patient pathways, clinical decisions, techniques employed, and reproductive outcomes observed after remission, in order to identify potential areas for improvement in the support and follow-up of these patients, thereby enhancing the overall quality and coordination of care.
This work is conducted alongside the development of a fertility observatory at the Department of Medicine and Reproductive Biology, CHU Amiens-Picardie.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: CABRY-GOUBET Rosalie, Pr
- Phone Number: 33+3 22 08 80 00
- Email: cabry.rosalie@chu-amiens.fr
Study Locations
-
-
-
Amiens, France
- Recruiting
- CHU Amiens Picardie
-
Contact:
- Rosalie Cabry, Pr
- Email: Cabry.Rosalie@chu-amiens.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women
- Aged between 18 and 47 years
- Diagnosed with cancer or hematological disorders requiring potentially gonadotoxic treatment
- Having undergone a medical fertility preservation consultation
- Followed at Amiens Picardie University Hospital (CHU Amiens Picardie) in the department of Reproductive Medicine
- Currently in remission
- Having expressed non-opposition to participation in the study
Exclusion Criteria:
- Absence of remission
- Patients deprived of liberty by administrative or judicial decision, or placed under legal protection (guardianship or curators)
- Decline to participate in the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of an identifiable reproductive outcome
Time Frame: 1 year
|
Identifiable reproductive outcome are Spontaneous pregnancy, Use of preserved gametes or ovarian tissue (whether or not resulting in pregnancy), Use of donor oocytes, Discontinuation of the parenthood project
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type of fertility preservation method performed
Time Frame: 1 year
|
1 year
|
|
|
Time interval (in months) between diagnosis and fertility preservation
Time Frame: 1 year
|
1 year
|
|
|
Correlation between Age and occurance of an identifiable reproductive outcome
Time Frame: 1 year
|
Identifiable reproductive outcome are Spontaneous pregnancy, Use of preserved gametes or ovarian tissue (whether or not resulting in pregnancy), Use of donor oocytes, Discontinuation of the parenthood project
|
1 year
|
|
Time interval (in months) between fertility preservation and initiation of potentially gonadotoxic treatment
Time Frame: 1 year
|
1 year
|
|
|
Number of type of cancer associated with identifiable reproductive outcome
Time Frame: 1 year
|
Identifiable reproductive outcome are Spontaneous pregnancy, Use of preserved gametes or ovarian tissue (whether or not resulting in pregnancy), Use of donor oocytes, Discontinuation of the parenthood project
|
1 year
|
|
Correlation between type of treatment and occurence of an identifiable reproductive outcome
Time Frame: 1 year
|
Identifiable reproductive outcome are Spontaneous pregnancy, Use of preserved gametes or ovarian tissue (whether or not resulting in pregnancy), Use of donor oocytes, Discontinuation of the parenthood project
|
1 year
|
|
Correlation between family status and occurence of an identifiable reproductive outcome
Time Frame: 1 year
|
Identifiable reproductive outcome are Spontaneous pregnancy, Use of preserved gametes or ovarian tissue (whether or not resulting in pregnancy), Use of donor oocytes, Discontinuation of the parenthood project
|
1 year
|
|
Time interval (in months) between completion of treatment and pregnancy attempt (spontaneous or medically assisted)
Time Frame: 1 year
|
1 year
|
|
|
Actual utilization rate of preserved material
Time Frame: 1 year
|
1 year
|
|
|
Success rate of reuse attempts
Time Frame: 1 year
|
1 year
|
|
|
Proportion of patients who ultimately did not pursue parenthood
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2025_843_0156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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