Impact of Breast Cancer on Human Folliculogenesis

NCT07148141 | Active Not Recruiting

• 1 other identifier: 2019_BRUGNON_FERTICAN
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer Female; Infertility, Female

Keywords

oncofertility; Breast cancer; Fertility preservation; Folliculogenesis; Cholesterol biosynthesis

Outcome Measures

Primary Outcomes (1)

• 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

  65 months

Secondary Outcomes (8)

• Assessment of Anti-Mullerian Hormone levels

  36 months

• Assessment of antral follicle count

  36 months

• Total dose of FSH administered

  36 months

• Number of harvested oocytes

  36 months

• Oocyte maturity

  36 months

Study Arms (2)

Breast cancer patients (BC)

Breast cancer subgroups (Triple-negative breast cancer (TN), Hormone-dependent breast cancer (HR+), HER2-amplified breast cancer (HER2+))

Other: Ovarian stimulation

Oocyte donors (OD)

Healthy women

Other: Ovarian stimulation

Interventions

Ovarian stimulation OTHER

Ovarian stimulation before oocytes retrieval

Breast cancer patients (BC); Oocyte donors (OD)

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients and oocytes donors

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

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

Location

MeSH Terms

Conditions

Infertility, Female; Breast Neoplasms

Interventions

Ovulation Induction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Florence Brugnon, MD, PhD, HDR

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 29, 2025
• Study Start: January 11, 2019
• Primary Completion: May 2, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 28, 2026

Record last verified: 2025-08

Locations

FR (1)