Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve

Infertility Clinical Trial

— IROCHIM  

Official title:

Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00712452
• Other study ID #: P070707
• Status: Terminated
• Phase: N/A
• First received: July 2, 2008
• Last updated: May 13, 2013
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: May 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infertility

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
France	AP-HP Hôpital Antoine Béclère	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMH level and antral follicle count		one year after the chemotherapy treatment	Yes
Secondary	AMH level and antral follicle count at each visit		3 months, 6 months, and two years after the chemotherapy treatment	Yes
Secondary	Hormonal status (Estradiol, LH, FSH and progesterone levels)		3 months, 6 months, and two years after the chemotherapy treatment	Yes
Secondary	Menstrual cyclicity		3 months, 6 months, and two years after the chemotherapy treatment	Yes
Secondary	pregnancy		3 months, 6 months, and two years after the chemotherapy treatment	Yes
Secondary	infertility treatment if required		3 months, 6 months, and two years after the chemotherapy treatment	Yes