Efficacy and Tolerance of an Ovarian Stimulation Protocol Combining Follicle Stimulating Hormone (FSH) and Degarelix Acetate in Female Candidates for Fertility Preservation Before Chemotherapy for Breast Cancer

What Was Tested

The trial (phase 2) is built around Degarelix for female fertility.

Currently, vitrification of oocytes and/or embryos after controlled ovarian stimulation is the most established method for female fertility preservation.

It had 1 arm (groups): one arm (other).

One arm.

The registry classes the interventions as drug.

More on the Plan

Currently, vitrification of oocytes or embryos after controlled ovarian stimulation (COS) represents the only established method.

In addition to requiring 15 days, COS induces supraphysiological hyperestradiolaemia (5-10 times normal) which can be problematic in case of hormone-sensitive tumors such as breast cancer.

Therefore, the limitation of serum estradiol concentrations during stimulation represents an important issue.

To this end, stimulation protocols combining aromatase inhibitors have been proposed.

Who Took Part

Enrollment: 8 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 10 inclusion and 2 exclusion criteria; among the exclusions: patient in late follicular phase or luteal phase; known hypersensitivity to one of the constituents of firmagon®.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Degarelix study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-11-28 with completion listed for 2022-03-31.

It ran at 1 site in France.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Number of follicles 16 to 20 mm in diameter obtained with estradiolemia <500 pg /mL (time frame: Day of ovulation trigger).

It also tracked 6 secondary outcomes, for example Serum estradiol levels, Percentage of women with hyperestradiolemia, Number of oocytes collected, Number of mature oocytes vitrified and Nature of serious side effects.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Degarelix in 8 people with female fertility.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Degarelix compound page, Female fertility research.