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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519644-33-00 | EU Trial (CTIS) Number |
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This study aims to evaluate the effectiveness of weekly administration of isotretinoin (40 mg) in increasing sperm production in men with oligozoospermia, a condition characterized by a low sperm count. Participants will be randomized into two groups: one receiving isotretinoin and the other a placebo. The primary outcome will be the change in sperm production over 20 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isotretinoin | Experimental | Isotretinoin (40 mg) orally, once per week for 20 weeks |
|
| control group | Placebo Comparator | Placebo identical in appearance and administration schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isotretinoin | Drug | ARESPERM is a multicenter, randomized, double-blind, placebo-controlled study that assesses whether a weekly dose of isotretinoin can stimulate spermatogenesis in men with oligozoospermia. The study hypothesizes that isotretinoin can trigger the differentiation of spermatogonial cells, leading to improved sperm production. |
| Measure | Description | Time Frame |
|---|---|---|
| Millions of Sperm Per Ejaculate | Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid | Day 0 |
| Millions of Sperm Per Ejaculate | Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid | Months 2 |
| Millions of Sperm Per Ejaculate | Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid | Months 5 |
| Millions of Sperm Per Ejaculate | Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid | Months 12 |
| Millions of Sperm Per Ejaculate | Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid | Months 24 |
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Inclusion Criteria:
Exclusion Criteria:
just man
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Hustache | Contact | 0388116768 | dpidrci@chru-strasbourg.fr | |
| Marius Teletin, MD | Contact | 03 69 55 35 30 | marius.teletin@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CECOS Alsace Strasbourg | Schiltigheim | 67300 | France |
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| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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|
| Control group (placebo) | Drug | placebo administration |
|
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |