Study Results
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Basic Information
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COMPLETED
PHASE4
65 participants
INTERVENTIONAL
2012-11-30
2024-12-31
Brief Summary
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Detailed Description
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At oocyte retrieval, aspirated follicular fluid is separated from the flush medium for hormonal assays, and oocytes are denuded for ICSI(Intra Cytoplasmic Sperm Injection) or vitrification. Cumulus cells are collected for subsequent analysis of oocyte quality gene expression.
A. Primary objective of the study is to evaluate efficiency of letrozole associated ovarian stimulation for fertility preservation in breast cancer patients in terms of oocyte maturation rate.
Patients' results for primary endpoint are prospectively compared to infertile patients undergoing COS without letrozole.
B. Secondary objectives of the study aim to evaluate safety of the protocol:
1. Estradiol and progesterone levels at ovulation triggering, ovulation and during luteal phase after oocyte retrieval (days 3 and 8)
2. The risk of disease relapse will be assessed by long-term follow-up of these patients (up to 5 years) as well as an evaluation of circulating tumoral DNA before and after ovarian stimulation.
3. Finally obstetrical outcomes will also be recorded.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Letrozole associated COS
Breast cancer patients undergo fertility preservation with letrozole associated COS for oocyte collection.
Letrozole is administered orally (5mg/day) during the entire stimulation protocol until ovulation triggering.
Letrozole
Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol Standard Protocol: letrozole is orally administered 2 tablets per day (2,5mgx2/d) from cycle day 2 throughout the ovarian stimulation with gonadotropins protocol until ovulation triggering. GnRH antagonist is administered as soon as at least one follicle reaches 14 mm.
"Random start" protocol: letrozole is administered throughout the stimulation together with gonadotropins and GnRH antagonist, until ovulation triggering.
Oocytes are collected 36h after ovulation triggering. All patients receive GnRH antagonist after oocyte retrieval for 3-7 days or until chemotherapy starts, to induce luteolysis.
Interventions
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Letrozole
Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol Standard Protocol: letrozole is orally administered 2 tablets per day (2,5mgx2/d) from cycle day 2 throughout the ovarian stimulation with gonadotropins protocol until ovulation triggering. GnRH antagonist is administered as soon as at least one follicle reaches 14 mm.
"Random start" protocol: letrozole is administered throughout the stimulation together with gonadotropins and GnRH antagonist, until ovulation triggering.
Oocytes are collected 36h after ovulation triggering. All patients receive GnRH antagonist after oocyte retrieval for 3-7 days or until chemotherapy starts, to induce luteolysis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Addressed to fertility preservation Unit before starting chemotherapy
Exclusion Criteria
* Known premature ovarian failure
* Basal FSH \> 20 IU(International Unit)
* Surgical contra-indications
18 Years
40 Years
FEMALE
No
Sponsors
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Erasme University Hospital
OTHER
Responsible Party
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Principal Investigators
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Isabelle Demeestere
Role: PRINCIPAL_INVESTIGATOR
Erasme-CUB
Locations
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Erasme-CUB
Brussels, , Belgium
Countries
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References
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Goldrat O, De Cooman M, Mailliez A, Delbaere A, D'Orazio E, Demeestere I, Decanter C. Efficacy and safety of controlled ovarian hyperstimulation with or without letrozole for fertility preservation in breast cancer patients: A multicenter retrospective study. Eur J Cancer. 2022 Oct;174:134-141. doi: 10.1016/j.ejca.2022.07.017. Epub 2022 Aug 20.
Goldrat O, Delbaere A, Demeestere I. Impact of letrozole-associated controlled ovarian hyperstimulation on ART outcomes and endocrinological parameters. Hum Reprod. 2022 Oct 31;37(11):2722-2723. doi: 10.1093/humrep/deac206. No abstract available.
Goldrat O, Gervy C, Englert Y, Delbaere A, Demeestere I. Progesterone levels in letrozole associated controlled ovarian stimulation for fertility preservation in breast cancer patients. Hum Reprod. 2015 Sep;30(9):2184-9. doi: 10.1093/humrep/dev155. Epub 2015 Jun 24.
Goldrat O, Van Den Steen G, Gonzalez-Merino E, Dechene J, Gervy C, Delbaere A, Devreker F, De Maertelaer V, Demeestere I. Letrozole-associated controlled ovarian hyperstimulation in breast cancer patients versus conventional controlled ovarian hyperstimulation in infertile patients: assessment of oocyte quality related biomarkers. Reprod Biol Endocrinol. 2019 Jan 3;17(1):3. doi: 10.1186/s12958-018-0443-x.
Other Identifiers
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BC-POF 2012
Identifier Type: -
Identifier Source: org_study_id
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