Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2012-003412-31-BE
EUCTR2012-003412-31-BE
Active, not recruiting
Not Applicable

Efficiency and Safety of Ovarian Stimulation with Letrozole for fertility preservation in breast cancer patients. - BROVALE

CUB - Hôpital Erasme0 sitesSeptember 3, 2012
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsThe aim of this trial is to offer a safe and efficient alternative protocol to preserve fertility by storing oocytes in breast cancer patients before chemotherapy. Letrozole, an inhibitor of aromatase, is administered during standard gonadotropins ovarian stimulation to maintain a low estradiol level during ovarian stimulation in patients with hormono-sensitive tumour.MedDRA version: 18.1Level: LLTClassification code 10006190Term: Breast cancer invasive NOSSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10016465Term: Fertility female decreasedSystem Organ Class: 100000004872MedDRA version: 18.1Level: LLTClassification code 10016463Term: Fertility decreased femaleSystem Organ Class: 100000004872Therapeutic area: Diseases [C] - Cancer [C04]
DrugsFemaraGonal-f 300IUGonal-f 900IUCétrotideMenopur 75IUDecapeptyl 0,1mgBemfola 150UI/0,25 mlBemfola 225 UI/0,375mlBemfola 300 UI/0,375ml

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
The aim of this trial is to offer a safe and efficient alternative protocol to preserve fertility by storing oocytes in breast cancer patients before chemotherapy. Letrozole, an inhibitor of aromatase, is administered during standard gonadotropins ovarian stimulation to maintain a low estradiol level during ovarian stimulation in patients with hormono-sensitive tumour.
Sponsor
CUB - Hôpital Erasme
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 3, 2012
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
CUB - Hôpital Erasme

Eligibility Criteria

Inclusion Criteria

  • •\-Woman 18\-40 years old with breast cancer
  • •\-Referred for fertility preservation at least 13 days before starting chemotherapy
  • •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 54
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 0

Exclusion Criteria

  • •\-Breast cancer TxNxM1
  • •\-Premature ovarian failure
  • •\-Poor ovarian function FSH\>20mIU/ml
  • •\-Surgical contraindication

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Comparison of the difference in the number of oocytes obtained by administering the ovarian stimulation treatment as usually with administering it only once and later.
EUCTR2019-001343-44-ESInstituto Bernabeu180
Completed
Phase 2
Assessment the effect of ovarian stimulation with and without letrozole in IVF/ICSI outcomes.
IRCT201701291952N8Vice Chancellor for research, Tehran University of Medical Science160
Recruiting
Not Applicable
The verification of safety and efficacy of ovarian tissue and oocyte cryopreservation for child patients.
JPRN-UMIN000040576St. Marianna University School of Medicine50
Completed
Not Applicable
Comparison of controlled ovarian stimulation with clomiphen citrate HMG(Human menopausal gonadotropin) or clomiphen citrate rFSH(recombinant follicule stimulating hormon) in IUI(Intrauterine Insemination) cycles.Condition 1: Unexplained infertility. Condition 2: Male factor infertility.Female infertility, unspecifiedOligospermia NOS
IRCT201109163386N4Semnan University of Medical Sciences142
Recruiting
Not Applicable
Evaluation of ovarian stimulation using ultra low dose rhFSH for unexplained infertilityunexplained infertility
JPRN-UMIN000013957Hirosaki University120