Breast Cancer FemaleFERTICANNCT07148141
Impact of Breast Cancer on Human Folliculogenesis
An observational study of Breast Cancer Female and Infertility, Female, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Advances in cancer diagnosis and treatments have improved the 5-year survival rate for patients over the last decade. Nevertheless, cancer treatments frequently alter patient's fertility, thus compromising their ability to conceive a child after remission. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Breast Cancer Female, Infertility, Female
- What is being tested?
- Ovarian stimulation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2019to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Study population: Breast cancer patients and oocytes donors
Who may be able to join
- Women above 18 years old and below 38 years old
- First hormonal stimulation cycle
- No dysovulation
- No cancer treatments prior fertility preservation (tumour resection, chemotherapy, radiotherapy)
- Women capable of giving written informed consent to participate in the research study
- Affiliated to social welfare service
Who cannot join
- Women below 18 years old and above 38 years old
- Endocrine disease
- Endometriosis
- Any cancer treatments prior fertility preservation (tumour resection, chemotherapy, radiotherapy)
- Previous hormonal stimulation cycle of less than six months
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne Rhones-Alpes, 63000
About this study
Official title: Fertility Preservation for Patients With Breast Cancer: Altered Response to Ovarian Stimulation and Loss of Cholesterol Homeostasis in Ovarian Follicles
Advances in cancer diagnosis and treatments have improved the 5-year survival rate for patients over the last decade. Nevertheless, cancer treatments frequently alter patient's fertility, thus compromising their ability to conceive a child after remission. Consequently, it is recommended to propose fertility preservation to patients before cancer therapy. The reference technique for preserving women's fertility the vitrification of mature oocytes after hormonal stimulation. In the context of cancer, different studies have shown that ovarian response to stimulation seems to be altered compared to healthy context, with a reduced number of mature oocytes collected, and altered oocyte quality, thus reducing the number of oocytes capable of producing a viable embryo. Hence, cancer seems to exert a deleterious impact on women's fertility. Nevertheless, the mechanisms by which the cancer may impair the ovarian functions are poorly understood. This innovative project aims to study the impact of breast cancer itself (the most frequent cancer in reproductive-aged women) on ovarian functions, and more precisely on the cholesterol biosynthesis pathway. Indeed, cholesterol homeostasis is essential for oocyte maturation and fertilization. The objectives of this study are i) to evaluate the impact of breast cancer on ovarian reserve and response to hormonal stimulation according to the molecular subtypes of breast cancer and ii) to evaluate the impact of breast cancer on ovarian cholesterol homeostasis in granulosa cells and follicular fluids.
This original approach will improve the understanding of the mechanisms underlying the impact of breast cancer on ovarian functions, and will have a strong clinical impact by helping to optimize fertility preservation strategies based on tumour molecular subtypes.
Read the detailed description
Breast cancer patients (stratified into three molecular subgroups based on tumour hormonal status: HR+, HER2+, or triple-negative (TN)) and healthy oocyte donors (OD) are included in this study. During oocyte retrieval (for fertility preservation or oocyte donation), cumulus-oocyte complexes (COCs) are collected following ovarian stimulation. COCs are treated with hyaluronidase to separate the oocytes from surrounding cumulus granulosa cells. Clinical data regarding ovarian reserve and response to stimulation are collected.
Comparative analyses are conducted between breast cancer patients and oocyte donors, as well as between each molecular subgroup (TN vs. OD, HR+ vs. OD, HER2+ vs. OD). Following retrieval, granulosa cells and follicular fluids are collected. Total RNA is extracted from cumulus cells for RT-qPCR quantification of key enzymes and regulators involved in the cholesterol biosynthesis pathway. In parallel, cholesterol levels in follicular fluid are quantified using GC-MS/MS or FID-MS/MS.
This extended protocol enables both clinical and molecular comparisons to assess how breast cancer subtypes may differentially impact ovarian response and follicular environment
- Conditions
- Breast Cancer Female, Infertility, Female
- Being tested
- Ovarian stimulation
- Keywords
- oncofertility, Breast cancer, Fertility preservation, Folliculogenesis, Cholesterol biosynthesis
- Medical subject headings
- Infertility, Female, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian stimulationOther
Ovarian stimulation before oocytes retrieval
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients (BC) | Breast cancer subgroups (Triple-negative breast cancer (TN), Hormone-dependent breast cancer (HR+), HER2-amplified breast cancer (HER2+)) Receives: Other: Ovarian stimulation | |
| Oocyte donors (OD) | Healthy women Receives: Other: Ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility preservation for patients with breast cancer: Altered response to ovarian stimulation and loss of cholesterol homeostasis in ovarian follicles
After oocyte retrieval, total RNA of granulosa cells from breast cancer patients and oocyte donors, will be extracted. Following retro transcription, qPCR will be performed
Measured: 65 months
Secondary outcomes (8)
Assessment of Anti-Mullerian Hormone levels
Ovarian reserve, assessed by Anti-Müllerian Hormone (AMH) levels, will be compared between oocyte donors and breast cancer patients according to molecular subtypes (TN, HR+, HER2+), BRCA mutation status, tumor grade, and lymph node involvement.
Measured: 36 months
Assessment of antral follicle count
Ovarian reserve, assessed by antral follicle count, will be compared between oocyte donors and breast cancer patients according to molecular subtypes (TN, HR+, HER2+), BRCA mutation status, tumor grade, and lymph node involvement.
Measured: 36 months
Total dose of FSH administered
Ovarian response parameters, assessed by the total dose of FSH administered, will be compared between oocyte donors and breast cancer patients according to molecular subtypes (TN, HR+, HER2+), BRCA mutation status, tumor grade, and lymph node involvement.
Measured: 36 months
Number of harvested oocytes
Ovarian response parameters, assessed by the numver of harvested oocytes, will be compared between oocyte donors and breast cancer patients according to molecular subtypes (TN, HR+, HER2+), BRCA mutation status, tumor grade, and lymph node involvement.
Measured: 36 months
Oocyte maturity
Ovarian response parameters, assessed by the number of mature oocytes, will be compared between oocyte donors and breast cancer patients according to molecular subtypes (TN, HR+, HER2+), BRCA mutation status, tumor grade, and lymph node involvement.
Measured: 36 months
Oocyte atresia
Ovarian response parameters, assessed by the number of atretic oocytes, will be compared between oocyte donors and breast cancer patients according to molecular subtypes (TN, HR+, HER2+), BRCA mutation status, tumor grade, and lymph node involvement.
Measured: 36 months
Impact of breast cancer on enzymes and regulators of the cholesterol biosynthetic pathway
Gene expression levels of enzymes (HMGCoA Réductase, SQLE, LSS, CYP51, DHCR7, DHCR24) and regulators (SREBP2, SCAP, INSIG, LXRa, LXRb) of the cholesterol biosynthesis will be assessed in cumulus cells by RT-qPCR and compared between breast cancer patients according to the molecular subtypes (TN, HR+, HER2+) and oocyte donors.
Measured: 36 months
Quantification of cholesterol and its intermediates in follicular fluids of Breast Cancer patients and Oocytes Donors
Quantification of cholesterol and its intermediates will be assessed in follicular fluids by GC-MS/MS or GC-MS/FID and compared between breast cancer patients according to the molecular subtypes (TN, HR+, HER2+) and oocyte donors.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start11 Jan 2019
- Primary completion2 May 2025
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Brugnon, MD, PhD, HDR, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148141
- Sponsor's protocol ID
- 2019_BRUGNON_FERTICAN
- Acronym
- FERTICAN
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Preservation for Patients With Breast Cancer: Altered Response to Ovarian Stimulation and Loss of Cholesterol Homeostasis in Ovarian Follicles
- ClinicalTrials.gov ID
- NCT07148141
- Acronym / sponsor ID
- FERTICAN / 2019_BRUGNON_FERTICAN
- Conditions
- Breast Cancer Female, Infertility, Female
- Keywords
- oncofertility, Breast cancer, Fertility preservation, Folliculogenesis, Cholesterol biosynthesis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advances in cancer diagnosis and treatments have improved the 5-year survival rate for patients over the last decade. Nevertheless, cancer treatments frequently alter patient's fertility, thus compromising their ability to conceive a child after remission. Consequently, it is recommended to propose fertility preservation to patients before cancer therapy. The reference technique for preserving women's fertility the vitrification of mature oocytes after hormonal stimulation. In the context of cancer, different studies have shown that ovarian response to stimulation seems to be altered compared to healthy context, with a reduced number of mature oocytes collected, and altered oocyte quality, thus reducing the number of oocytes capable of producing a viable embryo. Hence, cancer seems to exert a deleterious impact on women's fertility. Nevertheless, the mechanisms by which the cancer may impair the ovarian functions are poorly understood. This innovative project aims to study the impact of breast cancer itself (the most frequent cancer in reproductive-aged women) on ovarian functions, and more precisely on the cholesterol biosynthesis pathway. Indeed, cholesterol homeostasis is essential for oocyte maturation and fertilization. The objectives of this study are i) to evaluate the impact of breast cancer on ovarian reserve and response to hormonal stimulation according to the molecular subtypes of breast cancer and ii) to evaluate the impact of breast cancer on ovarian cholesterol homeostasis in granulosa cells and follicular fluids.
This original approach will improve the understanding of the mechanisms underlying the impact of breast cancer on ovarian functions, and will have a strong clinical impact by helping to optimize fertility preservation strategies based on tumour molecular subtypes.
Detailed description
Breast cancer patients (stratified into three molecular subgroups based on tumour hormonal status: HR+, HER2+, or triple-negative (TN)) and healthy oocyte donors (OD) are included in this study. During oocyte retrieval (for fertility preservation or oocyte donation), cumulus-oocyte complexes (COCs) are collected following ovarian stimulation. COCs are treated with hyaluronidase to separate the oocytes from surrounding cumulus granulosa cells. Clinical data regarding ovarian reserve and response to stimulation are collected.
Comparative analyses are conducted between breast cancer patients and oocyte donors, as well as between each molecular subgroup (TN vs. OD, HR+ vs. OD, HER2+ vs. OD). Following retrieval, granulosa cells and follicular fluids are collected. Total RNA is extracted from cumulus cells for RT-qPCR quantification of key enzymes and regulators involved in the cholesterol biosynthesis pathway. In parallel, cholesterol levels in follicular fluid are quantified using GC-MS/MS or FID-MS/MS.
This extended protocol enables both clinical and molecular comparisons to assess how breast cancer subtypes may differentially impact ovarian response and follicular environment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients (BC) | – | Other: Ovarian stimulationBreast cancer subgroups (Triple-negative breast cancer (TN), Hormone-dependent breast cancer (HR+), HER2-amplified breast cancer (HER2+)) |
| Oocyte donors (OD) | – | Other: Ovarian stimulationHealthy women |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Breast cancer patients and oocytes donors
Key inclusion criteria (6 listed)
- Women above 18 years old and below 38 years old
- First hormonal stimulation cycle
- No dysovulation
- No cancer treatments prior fertility preservation (tumour resection, chemotherapy, radiotherapy)
- Women capable of giving written informed consent to participate in the research study
Key exclusion criteria (5 listed)
- Women below 18 years old and above 38 years old
- Endocrine disease
- Endometriosis
- Any cancer treatments prior fertility preservation (tumour resection, chemotherapy, radiotherapy)
- Previous hormonal stimulation cycle of less than six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovarian stimulationOvarian stimulation before oocytes retrieval | Other | Breast cancer patients (BC), Oocyte donors (OD) |
Primary outcome
Fertility preservation for patients with breast cancer: Altered response to ovarian stimulation and loss of cholesterol homeostasis in ovarian follicles
Time frame: 65 months
After oocyte retrieval, total RNA of granulosa cells from breast cancer patients and oocyte donors, will be extracted. Following retro transcription, qPCR will be performed
8 secondary outcomes
Assessment of Anti-Mullerian Hormone levels
Time frame: 36 months
Assessment of antral follicle count
Time frame: 36 months
Total dose of FSH administered
Time frame: 36 months
Number of harvested oocytes
Time frame: 36 months
Oocyte maturity
Time frame: 36 months
Oocyte atresia
Time frame: 36 months
Impact of breast cancer on enzymes and regulators of the cholesterol biosynthetic pathway
Time frame: 36 months
Quantification of cholesterol and its intermediates in follicular fluids of Breast Cancer patients and Oocytes Donors
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Brugnon, MD, PhD, HDR principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Infertility, Female, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertility preservation for patients with breast cancer: Altered response to ovarian stimulation and loss of cholesterol homeostasis in ovarian follicles (time frame: 65 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.