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

Not Applicable

Terminated

• Conditions: Infertility
• Interventions: Other: Biology and ultrasonography after chemotherapy

• Registration Number: NCT00712452
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-09
• Study First Posted: 2008-07-10
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 19

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Biology and ultrasonography after chemotherapy	breast cancer
1	Biology and ultrasonography after chemotherapy	systemic lupus erythematosus
3	Biology and ultrasonography after chemotherapy	Hodgkin disease

Primary Outcome Measures

Name	Time	Method
AMH level and antral follicle count	one year after the chemotherapy treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AP-HP Hôpital Antoine Béclère; 🇫🇷 Clamart, France