Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, Prior Chemotherapy for Breast Cancer (PRESAGE)

March 26, 2026 updated by: Institut Cancerologie de l'Ouest

Pilot Study of Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, and Freezing Oocyte or Embryo Prior Chemotherapy for Breast Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

With 50 000 new cases per year, breast cancer is the most common cancer in women in France. About a quarter of breast cancers occurs before menopause and 7% before the age of 40 years. Due to the increased incidence of breast cancer in young women and declining age of first pregnancy, it is not unusual to have patient desiring pregnancy after treatment of a breast cancer. Among these women, the use of adjuvant therapy (chemotherapy, hormone therapy, chemical castration) is common. Adjuvant or neoadjuvant chemotherapy resulted in significantly lower recurrence rates and increase the survival of these patients, but these treatments could have more or less long-term consequences, including in ovarian function. Ovarian consequences of these therapeutic must also be explained to young patients. But it seems that this information is often inadequate or poorly understood, and then patients deplore to be faced with secondary infertility.

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44805
        • ICO René Gauducheau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • breast cancer history
  • History of another cancer in the last 5 years, with the exception of basal cell skin cancer and squamous cell
  • patient in pregnancy
  • pulmonary embolism under 6 months
  • deep vein thrombosis of less than 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tamoxifen stim in early follicular phase
Day cycle of the patient when ovarian stimulation begin (early follicular phase) = D1 to D3
Drug: Tamoxifen stim in early follicular phase

Day cycle of the patient when ovarian stimulation begin (early follicular phase) = D1 to D3

  • Stimulation with simultaneously: TAM (tamoxifen) 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve)
  • Monitoring (ultrasound + blood test E2, LH (luteinizing hormone) and P) every 2 to 3 days +/- dose adjustment of FSH
  • Ovulation by blocking the GnRH antagonist (gonadotropin-releasing hormone : CETROTIDE) introduced according to the usual criteria,
  • Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days
  • Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
  • 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia.
Other Names:
  • Hormotherapy
Other: Tamoxifen stim in late follicular phase
Day cycle of the patient when ovarian stimulation begin (late follicular phase) = D4 to D14
Drug: Tamoxifen stim in late follicular phase

Day cycle of the patient when ovarian stimulation begin (late follicular phase) = D4 to D14

  • Monitoring (ultrasound + blood test E2, LH and P) until a follicle of 15 mm
  • Ovulation induction by OVITRELLE® 250μg.
  • Continued monitoring (ultrasound + blood test E2, LH and P) 4 days after OVITRELLE® to the proper stage for the beginning of stimulation.
  • Stimulation with simultaneously: TAM 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve) + CETROTIDE
  • Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days +/- adaptation of FSH
  • Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
  • 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia.
Other Names:
  • Hormotherapy
Other: Tamoxifen stim in luteal phase
Day cycle of the patient when ovarian stimulation begin (luteal phase) = D15 to D28
Drug: Tamoxifen stim in luteal phase

Day cycle of the patient when ovarian stimulation begin (luteal phase) = D15 to D28

  • 1 or 2 Monitoring (ultrasound + blood test E2, LH and P) to check the validity of the post-ovulatory phase
  • Stimulation with simultaneously: TAM 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve) + CETROTIDE
  • Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days +/- adaptation of FSH
  • Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
  • 35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia
Other Names:
  • Hormotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the feasibility of ovarian stimulation combining tamoxifen with recombinant FSH (follicle stimulating hormone ) followed by oocyte vitrification and / or embryo freezing before chemotherapy for breast cancer.
Time Frame: max 1 month after beginning of stimulation (At the end of oocyte puncture after ovarian stimulation)

Assess the feasibility of ovarian stimulation combining tamoxifen with recombinant FSH (follicle stimulating hormone ) followed by oocyte vitrification and / or embryo freezing before chemotherapy for breast cancer.

=> evaluated by number of oocytes and / or embryos per patient.
max 1 month after beginning of stimulation (At the end of oocyte puncture after ovarian stimulation)

Secondary Outcome Measures

Outcome Measure
Time Frame
number of pregnancy obtain
Time Frame: At least 2 years After chemotherapy
At least 2 years After chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: BORDES Virginie, MD, Institut de Cancérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

July 17, 2017

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimated)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-N-2013-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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