Clinical trial · Observational
Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): End of study
Summary
Brief summary (as posted)
Breast cancer affect around 52 000 women in France each year. Amongst them, 7% are less than 40 years old and 2% are in between 25 and 35 years old. Significant therapeutic advances have improved the prognostic of these patients. They will all most likely to received chemotherapy. Despite the fact that chemotherapy has many side effects, these women do question the impact of the treatment on their ability to procreate. On 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when medical care potentially affect fertility. Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols, provide fertility information, and help individualize fertility preservation supports. Principal objective is to ensure the absence of ovarian stimulation's side effects and assess chemotherapy effects on child carrying potential.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fertility | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Adjuvant treatment
- description
- Patients in this group will be offered the option of ovarien cryopreservation as well as the follow up of the follicule stock during chemotherapy.
- label
- Neo adjuvant treatment
- description
- patients in this group will only have the follow up of the follicule stock.
Primary outcomes (2)
- measure
- change from baseline of Anti Mullerian Hormone (AMH) rate to different time points until 24 months
- timeFrame
- baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months
- description
- variation of percentages of AMH rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content
- measure
- change from baseline of account of antral follicles (CFA) rate to different time points until 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 38 Years
Show eligibility criteria text
Inclusion Criteria: * 18 ≤ age \< 38 * breast cancer histologically proved * under the control of an adjuvant chemotherapy or neo adjuvant chemotherapy * verbal agreement given Exclusion Criteria: * age ≥ 38 * metastatic breast cancer * non able to follow the design of the study (geographic, social or psychological reasons)
References
Publications (0)
Data not yet available