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NCT Number: NCT07148141

Impact of Breast Cancer on Human Folliculogenesis

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.

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Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne Rhones-Alpes, 63000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ovarian stimulation

Other

Ovarian stimulation before oocytes retrieval

Primary outcomes

  1. 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

Secondary outcomes

  1. Assessment of Anti-Mullerian Hormone levels

    Time frame: 36 months

    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.

  2. Assessment of antral follicle count

    Time frame: 36 months

    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.

  3. Total dose of FSH administered

    Time frame: 36 months

    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.

  4. Number of harvested oocytes

    Time frame: 36 months

    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.

  5. Oocyte maturity

    Time frame: 36 months

    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.

  6. Oocyte atresia

    Time frame: 36 months

    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.

  7. Impact of breast cancer on enzymes and regulators of the cholesterol biosynthetic pathway

    Time frame: 36 months

    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.

  8. Quantification of cholesterol and its intermediates in follicular fluids of Breast Cancer patients and Oocytes Donors

    Time frame: 36 months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Fertility Preservation for Patients With Breast Cancer: Altered Response to Ovarian Stimulation and Loss of Cholesterol Homeostasis in Ovarian Follicles

Acronym: FERTICAN

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Aug 29, 2025
Registry last updated
Jan 28, 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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