NCT03947151

Brief Summary

The present investigation aims to evaluate the efficacy of an innovative protocol of controlled ovarian stimulation for breast cancer patients, who are candidates for fertility preservation. Currently, vitrification of oocytes and/or embryos after controlled ovarian stimulation is the most established method for female fertility preservation. However, this stimulation induces an increase in serum estrogen levels, which is theoretically problematic in case of hormone-sensitive tumors such as breast cancer. The majority of oncology teams accept, in very specific situations (particularly when the tumor has been surgically removed), this ovarian stimulation, because the expected benefits of fertility preservation far outweigh the risks. However, everyone agrees that it would be more comfortable to be able to offer vitrification of oocytes and/or embryos using ovarian stimulation without increasing estrogen levels. In this research, investigators will evaluate the efficacy of degarelix (Firmagon®), currently indicated for the treatment of prostate cancer, as an innovative ovarian stimulation procedure. Administered at the beginning of ovarian stimulation, they believe it should maintain serum estradiol levels at physiological values at the end of stimulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

November 28, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

January 17, 2019

Last Update Submit

March 26, 2026

Conditions

Invasive Ductal Breast Carcinoma

Keywords

Fertility preservationControlled ovarian stimulationOocyte vitrificationGnRH antagonist protocol

Outcome Measures

Primary Outcomes (1)

  • Number of follicles 16 to 20 mm in diameter obtained with estradiolemia <500 pg /mL

    Success of the procedure if at least 4 follicles 16 to 20 mm in diameter are obtained on the day of ovulation trigger (36 hours before oocyte collection) with estradiolemia \<500 pg / mL

    Day of ovulation trigger

Secondary Outcomes (6)

  • Serum estradiol levels

    Day of ovulation trigger

  • Percentage of women with hyperestradiolemia

    from the beginning of the controlled ovarian stimulation until Month 2

  • Duration of the increase in serum estradiol levels

    from the beginning of the controlled ovarian stimulation until Month 2

  • Number of oocytes collected

    through oocyte collection, an average of Day 20

  • Number of mature oocytes vitrified

    through oocyte collection, an average of Day 20

  • +1 more secondary outcomes

Study Arms (1)

one arm

OTHER

one arm

Drug: Degarelix injection(s)

Interventions

Degarelix injection(s)DRUG

1 or 2 degarelix injection(s)

Also known as: Firmagon®
one arm

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with invasive ductal carcinoma breast cancer, whatever the hormonal receptor expression profile
  • Age : 18 - 40 years
  • Presence of 2 ovaries
  • Antral follicular count between 12 and 30 on both ovaries and/or recent measurement of serum anti-Müllerian hormone between 1.5 and 4 ng / mL (between Day-25 and Day0)
  • Indication of chemotherapy
  • Indication of preservation of fertility according to an oocyte vitrification technique after controlled ovarian stimulation (COS)
  • Patient in the early follicular phase of the cycle at the start of the controlled ovarian stimulation (COS) (absence of follicle\> 10 mm in ultrasound and estradiolemia \<50 pg / mL)
  • Oncology team agreement for the controlled ovarian stimulation (COS)
  • Social insured patient
  • Patient who gave her consent to participate by signing the consent of the study

You may not qualify if:

  • Patient in late follicular phase or luteal phase
  • Known hypersensitivity to one of the constituents of Firmagon®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Antoine Béclère

Clamart, 92140, France

Location

MeSH Terms

Conditions

Carcinoma, Ductal, Breast

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Carcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michaël GRYNBERG, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

May 13, 2019

Study Start

November 28, 2019

Primary Completion

March 31, 2022

Study Completion

August 30, 2022

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)