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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

July 17, 2017

Study Completion Date

January 31, 2028

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"

Trial Locations (1)

44805

ICO René Gauducheau, Nantes

All Listed Sponsors
lead

Institut Cancerologie de l'Ouest

OTHER