NCT00712452

Brief Summary

The objective is to evaluate the influence of chemotherapy, either for auto-immune disease, either for carcinologic disease, on clinical and biological markers of ovarian reserve, for young patients, with normal reproductive functions.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

July 2, 2008

Last Update Submit

May 13, 2013

Conditions

Infertility

Keywords

fertilitychemotherapy

Outcome Measures

Primary Outcomes (1)

  • AMH level and antral follicle count

    one year after the chemotherapy treatment

Secondary Outcomes (5)

  • AMH level and antral follicle count at each visit

    3 months, 6 months, and two years after the chemotherapy treatment

  • Hormonal status (Estradiol, LH, FSH and progesterone levels)

    3 months, 6 months, and two years after the chemotherapy treatment

  • Menstrual cyclicity

    3 months, 6 months, and two years after the chemotherapy treatment

  • pregnancy

    3 months, 6 months, and two years after the chemotherapy treatment

  • infertility treatment if required

    3 months, 6 months, and two years after the chemotherapy treatment

Study Arms (3)

1

OTHER

systemic lupus erythematosus

Other: Biology and ultrasonography after chemotherapy

2

OTHER

breast cancer

Other: Biology and ultrasonography after chemotherapy

3

OTHER

Hodgkin disease

Other: Biology and ultrasonography after chemotherapy

Interventions

Biology and ultrasonography after chemotherapyOTHER

Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)

Also known as: cyclophosphamide
1

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women volunteers treated by chemotherapy,
  • ≥ 18 and ≤ 35 years old
  • Regular menstrual cyclicity, between 25 and 35 days
  • Social security affiliation
  • Signed informed consent

You may not qualify if:

  • Women \< 18 and \> 35 years old
  • Pregnancy
  • Emergent treatment necessity
  • No social security affiliation
  • Virgin patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP Hôpital Antoine Béclère

Clamart, 92141, France

Location

MeSH Terms

Conditions

Infertility

Interventions

Biological FactorsCyclophosphamideFluorouracilTaxoidsDoxorubicinVinblastineDaunorubicin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Renato Fanchin, MD

    Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 10, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 14, 2013

Record last verified: 2013-05

Locations

FR(1)