NCT02890082Active, not recruitingPhase 2
Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, Prior Chemotherapy for Breast Cancer
Pilot Study of Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, and Freezing Oocyte or Embryo Prior Chemotherapy for Breast Cancer
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments. Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment. PRESAGE study offers to patients fewer than 40, to preserve their fertility before neoadjuvant or adjuvant chemotherapy for invasive breast cancer. The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or embryonic. This procedure is already done in many countries, and by some French teams, by combining tamoxifen or letrozole to the classic gonadotropin stimulation.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 102 (actual)
- First submitted
- 26 Aug 2016
- Start date
- Feb 2014
- Primary completion date
- Jul 2017
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Diseases
- Ovarian cancer
- NCT number
- NCT02890082
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 102
- From Feb 2014 to the primary completion date, Jul 2017
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- breast cancer history
- History of another cancer in the last 5 years, with the exception of basal cell skin cancer and squamous cell
- deep vein thrombosis of less than 6 months.
Other
- patient in pregnancy
- pulmonary embolism under 6 months
Who the study is looking for
- Aged between 18 and 40
- infiltrating breast carcinoma histologically proven
- Indication of adjuvant or neoadjuvant chemotherapy
- T0-T1-T2-T3
- N0-N1-N2a
- M0 after staging
- AMH ≥1 ng / mL and / or account antral follicles ≥ 5
- HIV serology negative.
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICO René Gauducheau Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.