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

Summary

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.

Conditions

• Breast Cancer

Interventions

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.

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.

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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest

  lead OTHER

Principal Investigators

• BORDES Virginie, MD · Institut de Cancérologie de l'Ouest

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2017-07-17

Completion

2028-01-31

Countries

• France

Study Locations