COmbining Interventions of fertility preservation to Mitigate fertility loss after BReAst cancer - COIMBRA

Phase 1

• Conditions: Female patients with breast cancer; MedDRA version: 20.0Level: PTClassification code 10006279Term: Breast neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2020-005914-16-BE
• Lead Sponsor: niversitair Ziekenhuis Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-01
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

-Age 18-35 years
-BMI 18-35 kg/m²
-Diagnosis of breast cancer
-Presence of 2 ovaries
-Signed informed consent form
-Medically fit for general anesthesia (ASA score 1-3)
-Permission of oncology team (with agreement to postpone chemo/radiotherapy for at least 2 weeks)
-Random start controlled ovarian stimulation (follicular or luteal phase)
-AFC minimum (ie antral follicles measuring between 2-9 mm): 8 antral folli-cles

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Age <18 or >35 years
-BMI <18 or >35 kg/m²
-Difference in AFC between the ovaries of more than 7 antral follicles
-Diagnosis of PCOS
-Previous radiotherapy and/or chemotherapy (neo-adjuvant chemotherapy included)
-Endometriose rAFS 3-4
-Allergy or reaction to the use of Elonva®, Puregon®, Orgalutran®, Pregnyl® Gonapeptyl®, Decapeptyl® or letrozole in the past

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified