Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)

  • STATUS
    Recruiting
  • End date
    Jan 25, 2027
  • participants needed
    565
  • sponsor
    Erasme University Hospital
Updated on 19 February 2024
cancer
breast cancer
breast carcinoma
letrozole
stage iv breast cancer
adjuvant chemotherapy
ovarian stimulation
fertility preservation
adjuvant
breast neoplasm
breast neoplasm malignant female

Summary

This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.

Description

Patients enrolled in this study undergo standard or "random start" ovarian stimulation with Gonadotropins using antagonist protocol before the beginning of chemotherapy. Ovulation is triggered in all patients with a GnRH agonist.

After retrieval, oocytes are denuded and matured oocytes are subjected to fertilization before embryo freezing or direct vitrification.

Primary objective is to evaluate the efficacy of performing a controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy in terms of mature oocytes collected.

Details
Condition Breast Neoplasm Malignant Female
Age 18years - 40years
Treatment Letrozole, standard-stimulated cohort
Clinical Study IdentifierNCT04289805
SponsorErasme University Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of invasive non-metastatic breast cancer (i.e. stage I to III)
Breast cancer diagnosis 18 and 40 years
No prior history of gonadotoxic treatments
Fertility preservation counseling for fertility preservation
Written inform consent
FSH < 20 UI/L and/or antra-follicular count 6 (follicles of 2-9 mm) and/or AMH 6 pmol (only applicable for patients who undergo controlled ovarian stimulation for embryo/oocyte cryopreservation)

Exclusion Criteria

Newly diagnosed stage IV breast cancer (i.e. de novo metastatic breast cancer)
Prior diagnosis of other malignancies before breast cancer
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.