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Active, not recruiting Observational

Impact of Breast Cancer on Human Folliculogenesis

NCT07148141 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2019-01-11
Last updated
2026-01-28

Condition(s) studied

Breast Cancer FemaleInfertility, Female

Investigational drug(s) / intervention(s)

Ovarian stimulation

Ovarian stimulation: Ovarian stimulation before oocytes retrieval

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
38 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Fertility preservation for patients with breast cancer: Altered response to ovarian stimulation and loss of cholesterol homeostasis in ovarian follicles — 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

Trial sites (1)

FacilityCityRegionStatus
CHU Clermont-Ferrand Clermont-Ferrand Auvergne Rhones-Alpes
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07148141 on ClinicalTrials.gov ↗ ← All trials in France