Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00712452

Purpose

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.

Condition	Intervention
Infertility	Other: Biology and ultrasonography after chemotherapy Other: Biology and ultrasonography after chemotherapy

MedlinePlus related topics: Infertility Ultrasound

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Fluorouracil Progesterone Vinblastine Vinblastine sulfate Bleomycin Bleomycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

AMH level and antral follicle count [ Time Frame: one year after the chemotherapy treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

AMH level and antral follicle count at each visit [ Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment ] [ Designated as safety issue: Yes ]
Hormonal status (Estradiol, LH, FSH and progesterone levels) [ Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment ] [ Designated as safety issue: Yes ]
Menstrual cyclicity [ Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment ] [ Designated as safety issue: Yes ]
pregnancy [ Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment ] [ Designated as safety issue: Yes ]
infertility treatment if required [ Time Frame: 3 months, 6 months, and two years after the chemotherapy treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	126
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 systemic lupus erythematosus	Other: Biology and ultrasonography after chemotherapy Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)
2 breast cancer	Other: Biology and ultrasonography after chemotherapy Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)
3 Hodgkin disease	Other: Biology and ultrasonography after chemotherapy Study of markers of ovarian reserve: Estradiol, LH, FSH and progesterone levels and ultrasonographic antral follicle count (no made in current practice)

Detailed Description:

The study will enrol patients between 18 and 35 years, treated with neoadjuvant or adjuvant chemotherapy for systemic lupus erythematosus (Group 1), breast cancer (Group 2) or Hodgkin disease (Group 3)to evaluate the clinical and biological markers of ovarian reserve. The follow-up will last 24 months for each patients with a visit before treatment, and at 3 months, 6 months, one year and two years after treatment.

During this period, we will collect pre and post treatment clinical data,and biological data and ultrasonographic data such as antral follicle count which is a marker of ovarian follicle reserve.These data were not observed in current practice.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712452

Contacts

Contact: Claire Basille, MD

+33 (0)1-4537 3622

claire.basille@abc.aphp.fr

Locations

France
AP-HP Hôpital Antoine Béclère
Clamart, France, 92141

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Study Director:

Renato Fanchin, MD

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

More Information

Responsible Party:	Clinical Research Delegation ( Yannick VACHER )
Study ID Numbers:	P070707
Study First Received:	July 2, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00712452
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

fertility
chemotherapy

Study placed in the following topic categories:

Infertility
Progesterone
Estradiol valerate
Vinblastine
Cyclophosphamide
Estradiol 17 beta-cypionate
Genital Diseases, Male
Bleomycin

Doxorubicin
Estradiol
Genital Diseases, Female
Fluorouracil
Estradiol 3-benzoate
Polyestradiol phosphate
Taxane

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Myeloablative Agonists

Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009