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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001121-17 | EudraCT Number |
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The purpose of this study is to determine the efficacy of a temporary ovarian suppression obtained by administration of a gonadotropin releasing hormone agonist during alkylating agents containing chemotherapy on ovarian reserve assessed by Anti-Müllerian hormone (AMH) serum levels in adolescents and young women with cancer.
This is a French, Prospective, Multicentre, Open, Randomised study To determine the efficacy of a temporary ovarian suppression obtained by administration of a Gonadotropin Releasing Hormone agonist (GnRHa) on maintaining ovarian reserve, patients will be randomized, half of them receiving Triptorelin extended release (LP) 3 mg intramuscularly every 28±3 days, starting at the inclusion visit and at least 72 days before chemotherapy with alkylating agents until 1 month after end of chemotherapy (mean duration: 12 months).
The primary objective of the study is to determine the effect of a temporary ovarian suppression achieved through administration of a gonadotropin releasing hormone agonist (triptorelin LP 3 mg) during alkylating agents containing chemotherapy on ovarian reserve assessed by AMH serum levels in adolescents and young women with cancer.
Number of centres 19 Research period
Statistical analysis:
Sample size and design One Hundred and sixty (160) patients will be included in this study in order to ensure at least 128 patients who will complete the study.
This number of patients should allow us to identify with a power of 80 % a difference of 5 pmol/L in AMH serum levels between the two groups, when accepting a risk alpha of 0.05.
Analysis populations The main analysis will be an intention-to-treat (ITT) analysis, which will be performed on all the randomized patients with a value of the main criterion of judgment (AMH level at M24). A per-protocol (PP) analysis will also be performed, as a secondary analysis, excluding patients with major protocol deviation defined a priori.
Primary criteria The value of AMH level at month 24will be compared between the two treatment groups using a test t of Student if AMH values are normally distributed and a non-parametric Wilcoxon test if not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin (GnRHa) + Chemotherapy | Experimental | Triptorelin LP 3 mg (DECAPEPTYL LP 3 mg, IPSEN) 3 mg every 28±3 days, intramuscular during chemotherapy |
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| Chemotherapy alone | No Intervention | Patient having a chemotherapy without drug injection for fertility preservation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin (GnRHa) + Chemotherapy | Drug | During her chemotherapy, the patient in the experimental arm will have regular injections of Triptorelin (DECAPEPTYL LP 3 mg, IPSEN) in order to preserve her fertility |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in AMH serum levels between both groups | Centralised hormonal dosages | at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with AMH serum levels < 5th percentile in each group | at 24 months | |
| Intra-patient variation in AMH serum levels between groups | Centralised hormonal dosages and study of potential factors associated with the efficacy of GnRHa co-treatment in preventing ovarian reserve loss (if there is one) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecile THOMAS-TEINTURIER, MD | AP-HP, Bicêtre Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Bicêtre Hospital | Le Kremlin-Bicêtre | 94270 | France |
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|
| up to 36 months |
| Antral Follicular Count (AFC) on ultrasound between the 2 groups | centralised blind evaluation by an independent reader on compact disc (CD) registration of AFC | at month 24 |
| Delay of resumption of menses between the 2 groups | Comparison of delay of resumption of menses between the 2 groups | up to the end of the follow up (an average of 3 years) |
| Levels of markers of ovarian reserve: AMH, Follicle-stimulating hormone (FSH), Estradiol between groups | Centralised hormon dosage | at months 12, 24 and 36 |
| Pregnancy rate in the 2 groups | up to the end of the follow up (an average of 3 years) |
| Adverse events related to Triptorelin co-treatment | up to the end of the follow up (an average of 3 years) |
| Relative change in Bone Mass Density (BMD) of the lumbar spine, left femoral neck and whole body in the 2 groups | centralised blind evaluation by an independent reader on CD registration of BMD assessed by dual-energy X-ray absorptiometry | at the baseline and at month 12 and month 36 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D012516 | Osteosarcoma |
| D008223 | Lymphoma |
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D013812 | Therapeutics |
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